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Dinsdag 13 november 2018 Aanpassingen: Restrictie nieuwe gebruikers: Nieuwe gebruikers van buiten het ziekenhuis dienen eerst goedgekeurd te worden door een Admin gebruiker. We hebben hier nu een uitzondering voor toegevoegd: als een nieuwe gebruiker van buiten het ziekenhuis wordt uitgenodigd op een studie dan hoeft deze gebruiker niet eerst goedge
Dinsdag 20 februari 2018 Aanpassingen: Er zijn een aantal verbeteringen doorgevoerd omtrent de audit trail, zoals: Een aantal engelse termen zijn in de Nederlandse versie aangepast. Enkele velden werden werden in het "Details" venster met interne Castor labels getoond, deze zijn aangepast naar meer begrijpelijke labels. Er zijn een aantal verbeterin
To set your study to live, you need the 'Manage Settings' right . Before you can set the study to live, you must complete the sections 'Study properties' (2) and 'Billing Information' (3) in the study's 'Settings' tab and ensure that you have selected a user in the 'main contact' dropdown in the 'General' (1) tab. Once the required details are
Please note - notifications can only be managed by system administrators. Castor SMS can generate tasks automatically, triggered by events. The predefined events are grouped into events within the study flow, study specific events and user related events. Inactive events will not trigger notifications. Events can be deactivated by selecting this opt
Dinsdag 4 juni 2019 Aanpassingen: Nieuwe externe gebruikers kunnen vanaf nu direct aangeven waarom zij toegang willen hebben tot Castor SMS. De reden wordt weergegeven in de automatische e-mail naar de Admin(s). Templates: De SMS variabelen voor Onderzoeksverpleegkundige, Deelnemende afdeling(en) en Vergaderdatum wetenschapsbureau zijn toegevoegd. D
Donderdag 17 mei 2018 Nieuwe functionaliteiten: De taken functionaliteit is vernieuwd. Vanaf nu kunnen gebruikers met een Admin rol middels Instellingen > Notificaties niet alleen automatische e-mails instellen, maar ook automatische taken. Taken kunnen ook handmatig aangemaakt worden. In het volgende manual item wordt uitgelegd hoe de taken func
With Castor CDMS you can capture your (medical) research data in a safe and secure way. It's easy to build the forms of your study yourself, without the need for programming knowledge. Castor CDMS has several advantages over commonly used alternatives such as Excel or Access, for example: by using Castor CDMS you can adhere to Good Clinical Pract
For English see below Dinsdag 11 februari 2020 Aanpassingen: Notificaties: De volgende e-mail variabelen zijn toegevoegd aan de gebeurtenis "Monitorvisite toegevoegd": Uitvoerende monitor - {{ executing_monitor }} Visite datum - {{ visitDate }} Type monitorvisite - {{ visitType }} De e-mail voor gebeurtenis "Studie goedgekeurd RvB" kan nu ook verstu
Castor EDC has been designed and developed to be in compliance with 21 CFR Part 11. Castor achieves compliance through a combination of risk assessment, SOP adherence, and establishing a structured validated system. It is however the System User’s responsibility to ensure that the software, as provided, is deployed and used in a manner that is comp
Yes you can. In the survey or survey package introduction or in the invitation email, use this syntax:  You need to replace /path/to/img with the actual url of the image. Example:  This does mean that the image has to be extracted from an online location and yo
If you're looking to import study data, check this article: Import study data. If you have questions about the format accepted in each field check Formats for data import. It is possible to import repeating data or repeated measure data, taking the following into consideration: The import file must contain the following columns: Participant ID, cu
Dinsdag 21 mei 2019 Aanpassingen: Multicenter: In het Deelnemende centra tabblad zijn de volgende velden toegevoegd: Startdatum Einddatum Beoogd inclusie aantal Huidig inclusie aantal Taken: De opmaakt van het Taken menu en het Taken tabblad is veranderd en is uitgebreid met de volgende informatie: Wanneer de taak is aangemaakt ("Aangemaakt op") Wie
Het Taken menu biedt een weergave van de taken (actiepunten). De studie gerelateerde taken worden ook in het Taken tabblad van een studie weergegeven. De taken functionaliteit biedt de volgende mogelijkheden: Inzien van taken Aanmaken van taken (handmatig of automatisch) Afronden van taken 1. Het inzien van taken De volgende taken zijn zichtbaar: Ta
As a full birth date might be considered personally identifiable information, using only the birth year or year and month of birth is a good alternative. It is still possible to calculate the age from these variables using a calculation field (although with less precision). Calculate the age of a patient from a birth year var a = moment(); var b = m
Enable Automation Engine In order to be able to access automations, you should first enable the Automation Engine in your Settings tab. Go to the 'Settings' tab, 'Study' sub tab. Select 'Other' tab. Select checkbox next to ‘Enable the Automation Engine’ Remember to click 'Save changes'. Go to the Automation Engine interface In order to create autom
Maandag 5 maart 2018 Aanpassingen: De automatisch gegenereerde e-mails door Castor SMS worden nu verstuurd vanuit no-reply@castorsms.com i.p.v. no-reply@castoredc.com De e-mail herinnering die naar studie contactpersonen wordt gestuurd over het indienen van een voortgangsrapportage wordt nu niet meer verstuurd als de status van de studie "Geen deeln
Before users can submit their study, they need to enter information and upload documents. Fields and documents can be made mandatory for all studies, or for studies that meet certain criteria. Follow the steps below to make a document mandatory: 1. To make a document mandatory, navigate to Settings > Configurations and click on the 'Workflow docu
Release date: 29 April 2021 Main features & improvements FormSync Creating linked study with duplicated study structure; process can be started from either a test or Real study type and the outcome will be a new study with the same structure but opposite type. ‘Go to study’ option to jump to the linked study added to allow users to easily switch
In clinical data collection, there are scenarios where data points cannot be entered due to specific reasons. The Mark as Missing feature allows users to indicate and document such cases systematically, ensuring compliance with Good Clinical Practice (GCP). Marking a Field as Missing To mark a field as missing, follow the steps below: Click the cogw
In this article, you'll learn how to create a survey. Surveys provide a way to send respondents, clients or patients, a questionnaire that will be linked to a Castor participant. This enables you to add additional patient reported outcomes (PRO) to the outcomes you have defined for your own data entry. Surveys are sent as part of a survey package
Discover how to easily record and monitor individual participant progress across clinical trials and studies in Castor CDMS. The Participants tab Navigate to the 'Participants' tab. Here, you have an overview of all of the participants in your study. You will automatically be taken to the 'List' view mode. There are two other views in which you ca
Before a survey package can be made available in the app, it has to be configured specifically for Castor Connect. When creating a survey package or editing an existing one, the "Edit survey package" window will appear where you can configure the details of the survey package: Name: This is the name that will be presented to the participant in the
It is possible to easily create a copy of a study that automatically duplicates the structure of the originating study with the Form Sync feature. Introduction to the Form Sync feature Our Form Sync feature allows for each production study to have a corresponding test environment. The test environment is for managing structural (CRF) changes, while
The following PDF files include role-based instructions for Castor eConsent. You can download or print these files for your own documentation: eConsent Organization Admin User Guide 2023.3 eConsent Study Admin User Guide 2023.3 eConsent Site User Guide 2023.3 eConsent Participant User Guide 2023.3
This guide will help you with creating an automation to show/hide visits/forms based on the Site. Before you start In order to be able to access the Automation Engine, you should first enable Automation Engine in your Settings tab. Go to the 'Study' tab and 'other' sub-tab . For the field 'Enable Automation Engine', select the checkbox and click 'S
All survey invitations that have been created and sent in the study appear in the 'Surveys' tab, where each row represent a separate survey invitation and contains several categories (columns). You can make use of this tab to lock and unlock surveys. The Lock icon allows users with required permissions to perform Lock/unlock actions directly from
Castor offers a 24X7 basic phone support which is to be used for reporting critical issues that require escalation (for example, Castor Connect application outage), and for basic issues (“how to” questions, access management, password help, etc). To reach the phone support, please use one of the following numbers based on the country from which you
A calculation field allows you to specify a formula or calculation in reference to variables present within the study. We have a calculation manual where you can find more information about how to use and create calculation templates. To make calculations with values of different fields, it must be possible to reference other fields. This is do
CDISC-ODM Export Format The CDISC Operational Data Model (ODM) was developed to promote data collection, archival and interoperability for clinical research studies. Castor CDMS supports CDISC ODM-XML for the study structure and data export. The base version of standard is ODM-XML version 1.3.2 This feature is currently available upon customer req
With the 2022.4 release we set the limits for all of the endpoints to 600 calls per 10 minutes for CDMS API. In the upcoming release (2022.5) we will start to enforce them. Questions What exactly is covered by a data request? We request the entire study per endpoint. Is that 1 request (per endpoint), or is it the number of pages within the request?
User roles are in essence a set of rights. You can use roles (predefined or custom) to easily define all the rights you want for each user. You also need user roles if you want to hide parts of the eCRF for certain users. Your browser does not support HTML5 video. The study admins will need the manage 'Users’ permission to be able to manage roles.
Export data into SPSS To export your Castor data into SPSS you will need to follow a few steps, please see below: Create an export file. When you want to export this file to SPSS, choose the option: SPSS Export file. Click "Export". The export file is now saved on your computer in a default download folder named: studyname_spss_export_datecode. I
Once you have created a survey and survey package, you can proceed with testing them. Firstly, you need to create a test participant and add your own email address. In that participant, create a survey invitation in the surveys tab. These are the same steps to be followed when sending surveys to the study participants. Upon sending the survey invit
There are multiple options to calculate the difference between dates. 1. getDateDiff The easiest approach is to use getDateDiff. See this calculation: getDateDiff('{date2}','{date1}','y') In this calculation: '{date2}' = the variable name of the date field that contains the most recent date '{date1}' = the variable name of the date field with the ol
Once your study is completed or if you have a test study which you would like to hide from the ‘My Studies’ overview, it is possible to archive it. Archiving a study works as "soft delete", which means that the study and all its data is retained in the archive and can always be unarchived. Archived studies cannot be opened, but remain in the studi
Tracking participants throughout the study lifecycle is critical. Whether processing individual participants, or summarized views of study progress, most users rely on this information for critical user-flows. The participant status feature allows users to easily define and manage participants statuses. These can then be assigned to single or multip
You can use Moment.js to compare two or three dates with each other. You can use this to build advanced dependencies or calculations. How to start More information about how to create a Moment.js object out of a field in Castor can be found here: Doing date calculations: the basics. var date = moment('{inclusionDate}', 'DD-MM-YYYY'); Compare two d
Planned release date: 8 March 2022 ENGLISH: System defect fixes: Castor SMS can send out a notification when the end date of a monitor is approaching. However, it was being sent 2 weeks after the end date instead of 2 weeks before. This has been corrected. Within a study, the study team overview is now showing the role of the users again. If an auto
The remark field allows displaying some information rather than entering data, for example a line of text that can be added to your forms to provide a user with more information and structure the form. Add the text you want to display in the 'label' section of the field. To add a remark field, select 'Remark' in the field type panel in the ‘Study
Add study amendment: Go to the 'Studies' overview. Open the study. Navigate to the 'Amendments' tab. Click on 'Add amendment'. Fill in the form. Click on 'Save'. The amendment is now added to the study. If documents were added to this amendment, these will be shown in the Documents tab, marked with the associated amendment number. Submit study amend
Patient safety is paramount in clinical research for that reason all adverse events must be participanted even if there is no causal relationship between the treatment. Serious Adverse Events in Castor EDC You can document Serious Adverse Events (SAE) or any other unintended event in Castor using Repeating data. As we can not predict if an adverse
Check out the article Using the "for loop" in calculations to see an explanation about how this calculation works. This template allows you to compare three or more fields (variables) with one specific field. You can also add extra variables to the list if you have more than 3, just by separating them with a comma: var main = {main_variable}; var ar
For English see below Dinsdag 11 augustus 2020, versie 2020.16 Aanpassingen: Notificatie gebeurtenis 'Studie is gestart' is toegevoegd en kan een e-mail en/of taak activeren zodra de studie op studiestatus 'Gestart' komt te staan. Als voorbereiding op het toevoegen van bulk acties in het Gebruikersmenu, is paginering aan het menu toegevoegd. In het
1. Creating fields When creating new fields, the 'Label' field is the actual question that will be displayed in the eCRF. It is advised to also use the 'Variable name' field. The variable name will assume the value entered in the respective field for each subject and is important for the export of data and your final analysis, as well as for any cal
What is a quote request Some studies require other departments to support in study actions. These are referred to as participating departments, and can be added to a study. Users can request a quote, an email will be sent to all users with the associated role in the participating department. Managing a request for a quote Go to the 'Studies' tab. Op
In the United States, the date format begins with the month and ends with the year (mm/dd/yyyy). Study admins can define a custom date format for each institute in the Settings tab. If you want to use an alternative format, we recommend you to use a text field. In this text field, you can use the formats: mm/dd/yyyy mm-dd-yyyy mm.dd.yyyy To chec
Email addresses can be linked directly to participants, which enables you to send surveys to subjects. The email attached to a participant will be pre-populated in any survey invitations created for that participant. Having an email address attached to a participant is a prerequisite to be able to send mass survey invites. You can still change the
This template checks if after the patient signed informed consent (date1) a visit has taken place (date2) between a day range. In this template: date1 and date2 are two date fields in your form. Replace them with your own variable names. XX and YY are the limits you want to use. Replace them with the number of days you want to check for, e.g. 0 and
When testing your calculation with checkboxes in the Calculation Helper , use commas (,) as separator instead of semicolon (;). On the contrary, Castor CDMS uses semicolon (;). Check if a box was checked Checkbox fields are saved as a semi-colon separated string, e.g. "1;4;5". To be able to perform calculations with these values, you will need
The Automation Engine is a relatively new feature which users can use to automate many of their tasks. The Automation Engine is still a beta feature and thus to use it you need to have beta features enabled. You can do this by going to the Settings tab, then go to the Study sub-tab. In the section 'Other' you should select Enable beta features. To g
In some cases only partial dates are known. For example only the month and the year is known. In this case you can create a text field and add a calculation field to make sure that the date is in the correct format. Use the following template to check for the date format DD/MM/YYYY and validate the date when only month and year is known NK/MM/YYYY
Learn how to create a printable version of your study forms. Print empty CRF Navigate to the 'Participants' tab. In the upper right corner, click on the 'Actions' button → then click on 'Print empty CRF': In the 'Print empty CRF' menu you can select the structure you want to print and indicate whether you wish to include additional details such
Once a study is complete, we recommend performing the following actions: Lock all participants Export a copy of the study data Set the study to 'Not Live' in the 'Settings' tab Remove all users and study admins can reduce their own rights . It is recommended that study admins leave themselves as the only user, and remove all user rights exce
Grid fields: The Grid fields are used to group closely related data and display it as a table in an eCRF. A grid can contain as many rows and columns as you like. The fields can be set as text, number, dropdown or date fields. Here is an example of a grid field as seen in the study forms: It is not possible to add a validation to each field, to make
It is possible to import a number of email addresses into their associated participants record from a csv-file. This can be useful if a large number of participants need to be migrated to Castor, if surveys are sent in bulk , or if you want to send survey invitations automatically to a large number of participants using the Automation Engine.
In the 'Repeating Data' tab, an overview of all the Repeating data instances within the study is shown. Please note that; Users can only view or print Repeating data from participants that belong to a site for which they have "View" rights. Users can only (un)archive repeating data Repeating data from participants that belong to an site for which th
What is a billing code? This is an alphanumeric or alphabetic code given after the contract is signed. This is used when it’s time to set your study to live. If your study is sponsored by a commercial entity, then you will need a billing code. The billing code should be entered in the 'Billing Information' section in the settings tab. See instructio
Castor EDC 2022.1 release certificate. 2022.1_Release_Certificate.pdf
Castor EDC 2020.2 release and randomization certificate. Release notes for 2020.2 can be found here. Castor_EDC_2020.2_release_notes.pdf Release_certificate_2020.2.pdf Randomization_certificate_2020.2.pdf
In this tutorial you will learn how to hide or show a form based on the randomization of a participant using the Automation Engine. Before creating an automation which will trigger the action of hiding a form, make sure the Automation Engine is enabled and all the Randomization settings are correct. Parameters Event: The subject is randomized to
Release date: 3 June 2021 Study Configuration ‘Castor Connect’ added to configuration options for internal (Castor) users to make Castor Connect configurable/usable within a study. The below Castor EDC features apply only to studies with Castor Connect turned ON. Ongoing studies are not/will not have access and/or visibility of the below unless requ
Follow the steps below to learn how to create, manage, and view repeating data instances for a participant. Prerequisites Edit permissions are required to create repeating data instances. If you do not see the options described below, contact your Study Manager to request the appropriate access. When starting a new study, there will be no repeating
Yes - uploaded files can be exported in bulk, into a zipped file. To export files from the study: Navigate to the Participants tab. Click the 'Export' button. Choose 'Export all' to export files from all participants. If you are exporting only selected participants, first select the participants of interest and then click Export and 'Selected Part
Repeating Data study structure can be used to register adverse events (AE) and also to record any other data which is not part of the main study protocol, for instance any unexpected hospital visits or emergency surgical procedure. Creating Repeating Data is almost the same as creating Visits - in the article below, you can learn about how to crea
Hiding a field which already contains data can be done by using dependencies. Before you start: Make sure that the study setting "clear inapplicable field child" is disabled (checkbox is unchecked) in order to prevent data loss. This can be done in Settings > Study > Other > "Clear inapplicable child fields". Please note that this setting
This guide will help you with creating an automation with the "Hide Form" action. In order to be able to access the Automation Engine, you should first enable beta features in your Settings tab. Go to the 'Settings' tab, 'Study' sub-tab , Scroll down to the section 'Other'. For the field 'Enable beta features', select 'Yes' and click 'Save changes'.
This article explains some important topics as you get started with building forms by creating Visits and forms. Before you begin this process, we recommend that you familiarise yourself with the study, repeating data and survey structure in Castor CDMS. To start creating Visits and forms, navigate to the 'Study Structure' tab, from the Study Des
Through Castor, it is possible to send surveys which can be completed either via a web browser (for example, Chrome, Firefox) or via Castor Connect app. Surveys created for web browsers Castor surveys can be used on mobile devices such as smartphones and tablets, but are not fully optimized for such use. That means that while everything will work no
If you are a monitor performing source data verification (SDV) you can mark forms and visits as source-data verified. The verification type first needs to be set up by the study admin, find out how here. To be able to verify a form, you need 'Verify' rights. Mark a form/visit as verified To mark a form or visit as verified, follow these steps: Open
In this article, you will learn how to invite additional users to your study. Before you are able to invite new users and manage existing ones, make sure you have the “Users” permission . Add a user In the 'Users' tab, click the '+ Add user' button to add a new study team member to the study: A pop-up will appear where you have to fill in the user
This article provides a step-by-step guide for creating and customizing a survey package in CDMS. A survey package in Castor CDMS is a module that allows researchers to design and administer surveys and questionnaires to study participants within the platform. You can also learn more about surveys within Castor Academy. Click here to view the Ca
Adding comments to a field A comment is a note that users can add to a field for additional context or information. Users with "View" permissions can check and enter comments to fields using the dedicated action. You can add multiple comments, but it's important to know that comments cannot be deleted or edited once added. When exporting study data
Yes, it does. Surveys can be used to let participants enter data themselves. This can save time for the researcher and gives the participant the ability to fill in the information at his own convenience. For more information about making surveys see the associated manual article - Creating a new survey It is also possible to use Castor Connect app t
This article covers how to change the way participant IDs are generated within Castor CDMS. Participant ID Options First, navigate to ‘Settings’ → ‘Study’ tab → ‘Other’. Click the ‘Participant ID’ dropdown to see the various options for customized participant ID's: Below are the options for customizing your participants IDs: Random number: Th
Use this template to add a month to a date, e.g. if the next visit has to be within a month after the first visit. Replace {date} with your own variable name. var date = moment('{date}', 'DD-MM-YYYY'); var newDate = date.add(1, 'months'); newDate.format('DD-MM-YYYY'); Test this template in the calculation helper. If you want to use different tim
When a web browser based survey was sent and locked, if the survey participant tries to open the survey, they will see this message: In Castor Connect locked / completed surveys are not available for re-completion or editing once submitted.
The 'Overseeing Organization & Sites' overview allows to change the details of the main organization, add new study sites and manage existing ones. Overseeing Organization In this section, you can view the following details related to the overseeing organization: Name, Abbreviation, Country, Admin email. Study sites In the study sites sect
In Castor, you can configure two-factor authentication (2FA) for your account. This means that, upon login, you will have to enter an extra authentication code generated by an authentication app on your phone or tablet. This adds an extra layer of security to your Castor account - potential attackers will need not only your account details, but als
Check with calculation To check if a repeating data instance (e.g. an SAE form) was added, you can check if a required variable name on the repeating data has been defined. You need the following syntax to achieve this: '##allowempty##'; if("{field_on_AE_repeating_data_structure}" == "'NA'"){ 'No'; } else { 'Yes'; } Note that '##allowempty##'
We've also provided an overview of the ISO standards and available ISO certificates here . ISO 27001 ISO 27001 is a standard that requires an organization to set up an information security management system (ISMS) that will safeguard the availability, integrity and confidentiality of the data that is handled by the organization. Castor has been IS
This tutorial will cover what an if/else statement is, when to use it, and how to use it. What is an if/else statement The if/else statement is a logical, conditional expression that evaluates a condition and will only execute the block of code below it, if the condition is true. An example in plain English: if (field 1 = 1 and field 2 = 2) { 'Perf
This article explains how to send out surveys to certain participants in your study automatically. This means that you can schedule surveys to be sent as soon as an email address is added to a participant or a field value is updated. To do this, you will need to use the Automation Engine. This tab will appear once you enable 'Beta' settings in the b
In this tutorial you will learn how to schedule and send several different surveys using Automation Engine. Parameters Event: * Email Address Added to Participant. Action: Create and Send Survey Package. In our study we have two surveys. We want to send our SF-36 survey (General Health Survey) as soon as an email added to the participant and the Med
1. To be able to access the eConsent platform, navigate to the login page based on the location of your study, US or Europe: US eConsent - https://us.castorconsent.com/ EU eConsent - https://eu.castorconsent.com/ 2. Enter your email address in the appropriate field. 3. Enter your password in the appropriate field. 4. Click the "Login" button to co
Wat is een goedkeuringsaanvraag? Een goedkeuringsaanvraag is een verzoek aan een partij/dienst om een akkoord te geven. Denk hierbij aan een akkoord van een jurist, financial controller, privacy deskundige of een medisch hulpmiddelen expert. Zodra een goedkeuringsaanvraag aan een studie is toegevoegd of ingediend dan worden de gebruikers met de geko
Please note - user roles and user rights can only be managed by system administrators. Castor SMS can generate roles automatically for approval requests and participating departments. A default set of user rights are automatically set up for these roles. Create a new participating department Go to the 'Settings' tab. Go to the 'Roles and rights'
For very short surveys where you don't know which language is needed, you can use dependencies. It is advisable to have all the dependent questions in one form. If the dependent questions are located in different forms, then this might lead to blank pages. For longer surveys, we advise to create different surveys and survey packages for each lang
Learn how to delete or archive repeating data instances, with step-by-step instructions. How to delete a repeating data instance You can only delete a repeating data instance if your study has not yet been set to Live. In the Participant Overview, go to the Repeating Data tab. Click the context menu (three dots) next to the repeating data instance y
The 'Upload file' field allows users and survey participants to upload files to the study. Exporting uploaded files can be done in two ways: Export per participant, per field: Files can be individually downloaded from the form using the View or Download options alongside the field. For studies using Large File Upload feature, it is only possible to
With the 2022.5 release Castor CDMS allows to include partial dates when configuring a date field in the CDMS form builder. Therefore, you can determine whether a missing day or day and month are permitted when entering a date datapoint. Once set, this action will be recorded in the study audit trail. This will be reflected in configured web surveys
To allow for medical coding of adverse events, medical history, and concomitant medications, we have implemented an out-of-the-box integration with a Medical Coding platform: MedCodr. MedCodr is a web based solution for coding medical verbatim terms and products to standard dictionaries including MedDRA and WHODrug or custom dictionaries. With
All IDs that you need to use for the API (except for the participant ID) are uppercase GUIDs in the format 8-4-4-4-12 characters, which generally look like: 93852ECC-18F1-4829-A453-87B924B08D84 The study ID can be found in the study settings in Castor CDMS or with the endpoint /study Participant IDs are the same as they are listed in the Partici
In het "Factuuradressen" tabblad kunnen alle factuuradressen van de studie worden bijgehouden. Denk hierbij aan bijvoorbeeld de sponsor(s) en subsidie verstrekkers. Overal waar in Castor SMS wordt gevraagd naar betalingsgegevens kan uit de hier toegevoegde factuuradressen gekozen worden. Het toevoegen van een factuuradres: Klik op de knop "Voeg fact
Your browser does not support HTML5 video. The 'Monitoring' module allows monitors to create data queries for fields in a study. These data queries or queries are issues the monitor has identified with the value entered in a field. Queries need to be closed for a participant to be marked as complete. This module is only available for studies th
In het tabblad "Deelnemende afdelingen" worden de deelnemende/ondersteunende afdelingen of diensten van de studie toegevoegd. Dit biedt een inzicht in het aantal verrichten die de afdeling specifiek voor de studie uitgevoerd moeten worden. Aan de hand hiervan kan de afdeling een offerte opstellen. Het toevoegen van een deelnemende afdeling: Ga naar
Before you follow the steps in this article, please make sure you have exported your data properly. See here how you can export to SPSS. Save your .sav files, e.g. 'studydata.sav' and 'reports_bloodpressure.sav'. If you want to merge files in a wide format (i.e., for every repeating data/survey instance, new columns are added), follow the steps be
It is possible to create one general survey link using the Open Survey feature. This generates a unique URL that allows participants to access and complete a survey without logging into the platform. To enable it, select the checkbox field for the option ‘Allow creation of open survey link’ when creating a survey package. Once activated, you can s
Er zijn 2 manieren om nieuwe rollen aan te maken: handmatig en automatisch. De rollen waarbij automatisch rechten worden gemaakt zijn van toepassing op de deelnemende afdelingen en goedkeuringsaanvragen. Dit onderdeel van de handleiding gaat over het maken en beheren van automatische rollen (gekoppeld aan deelnemende afdelingen en goedkeuringsaanvra
To be able to randomize participants, randomization must have been first enabled and set up. See Randomization settings for further information on how to set up the randomization for your study. We also have a workshop video on how to randomize a participant. Open a participant (that needs to be randomized) Once you have set up your randomization
As a researcher using Castor, you will comply with all GCP guidelines applicable to you in your role as sponsor and/or researcher. You can learn more here and on request, we can provide copies of the latest validation, testing reports and certificates for the latest version of Castor EDC/CDMS. You can submit your request via support@castoredc.com
What is eConsent? In the realm of clinical research, obtaining informed consent from participants is a fundamental step that ensures ethical standards and regulatory compliance are met. Traditionally, this process has been paper-based, requiring significant time and effort from both participants and researchers. However, with the advent of digital t
There are two ways to export data from your study to R: Export data in CSV format and read the CSV file into R (see below) Use the Castor API R package called castoRedc to retrieve data Read your CSV file into R Skip this step if you have retrieved data with the Castor API R package. Follow this step if you have exported your data in CSV format. Re
When streaming video and audio, such factors as software, internet speed, bandwidth stability, network security can affect the video/audio quality. In this article we will explain how to troubleshoot potential audio/video issues. Enabling video and microphone access in the browser Google Chrome is highly recommended to share your camera and screen.
Castor eConsent 2022.4.0.0 Release Certificate is available for download below. eConsent_2022.5.0.0_Release_Certificate.pdf
Your export is either Excel or a ZIP file which contains multiple files in the format of your choice. Along with the study, repeating data, and survey data, you will find additional files with comments, custom verifications, field options, queries, source data verifications for Forms, and variable lists. This article outlines how your data will be
Het is mogelijk om automatische e-mails te laten genereren. Deze worden verstuurd vanuit no-reply@castorsms.com.Ga naar het Instellingenmenu, subtabblad Notificaties. Het instellen van een automatische e-mail gaat in 4 stappen: 1. Selecteer een gebeurtenis2. Specificeer de ontvanger(s)3. Opstellen van de e-mail template4. Opslaan van de e-mail notif
There are multiple ways to calculate the age using dates. Here are some examples: Calculate current age (today's age) If you only have one date variable (date of birth), you can use the following formula: var d = new Date(); var datestring = d.getDate() + "-" + (d.getMonth()+1) + "-" + d.getFullYear(); getDateDiff(datestring,'{dob}','y'); In this ca
Woensdag 4 september 2019 Aanpassingen: Templates: Het is vanaf nu mogelijk om opsommingstekens toe te voegen bij de lijst met geëxporteerde actieve documenten; Middels de variabele ${currentDate} wordt de datum waarop de template wordt aangemaakt/gedownload weergegeven. Notificaties: De herinnering gebeurtenissen die meerdere malen geactiveerd kan
Castor CDMS has an Application Programming Interface (API) that supports authentication and authorization of API calls through the industry standard OAuth2. In this article you can learn about its authentication, documentation, and troubleshooting. Authentication Generate an API Client ID and Client Secret through your 'User Settings' page: With t
Castor CDMS can send you updates via email (notifications) of several predefined events as soon as they happen in the system. This article explains how to set up such notifications about certain events in your study. You can also learn more about notifications within Castor Academy. Click here to view the Castor Academy ‘EDC-CDMS - Notifications
Calculations with grid fields are also possible. For example, you can calculate the sum of a row or column in your grid. This of course makes sense if you are using numerical fields, but can sometimes apply to dropdown fields as well. Grid fields are stored as JSON objects. A JSON object looks like this: {"0":{"0":"A","1":"C"},"1":{"0":"B","1":"
Castor SMS 2022.x.x 21 CFR Part 11 Statement of Compliance is available for download below. CastorSMS_2022.x_21_CFR_Part_11_Assessment_of_Compliance.pdf
Castor EDC/CDMS currently supports file uploads, with a size limit of 5 mb per file. For medical imaging and other large files, we offer a premium feature - Large File Upload - which allows the upload and storage of larger files (up to 2GB per file) in Castor. Please contact us if you are interested in enabling large file storage for your study, o
Op maandag 11 december wordt Castor SMS versie 2017.3 gereleased. Toevoegingen & aanpassingen De taal van de automatische e-mails die vanuit Castor SMS verstuurd worden was altijd Engels. Nu is de taal van de automatische e-mails afhankelijk van de taalinstellingen van de gebruiker. De e-mailtemplates hebben een update gekregen, zo wordt het stu
In Castor, surveys are sent out by creating survey invitations. In order to send a survey you must first have created a survey form and a survey package. Surveys are always sent as survey packages, even if the package consists of only one survey. This article describes how to send out survey invitations to a single participant. To send a survey to m
Release date: 21 September 2021 For English see below DUTCH Systeem defect fixes: Wanneer een vraag verplicht wordt naar aanleiding van het antwoord op een andere vraag, werd de rode omlijning niet altijd getoond. Dit is nu opgelost. De error die soms getoond werd wanneer een CV of certificaat gedownload werd vanuit de profiel tab, is nu verwijderd.
Castor has multiple servers in different regions. The data in Castor SMS is by default stored on the server for the regio European Union, which is located in The Netherlands.
In the 'Participants' tab, an overview of all the participants within the study is available. A user can only see the participants that belong to the sites for which they have 'View' rights. The Participants tab explained The 'Participants' tab shows an overview of all the participants in your study. The Participant ID column is fixed to the left si
Please note - user roles and user rights can only be managed by system administrators. The user roles 'Guest', 'User', and 'Admin' are default Castor SMS roles and cannot be changed. It is possible to create additional user roles for your institute’s use. Add a new user role Go to 'Settings' tab. Open sub-tab 'Roles and rights'. Click 'Add role'. Ad
Your browser does not support HTML5 video. Data entry Only users with Edit, Encrypt and Decrypt permissions can add and edit data in an encrypted field. These users will see a key icon next to the field (even if there is no data): To view or enter data, the key icon needs to be clicked. This will either reveal the data that has been entered or al
The ‘Study structure’ tab is where you define the sequence of your study forms and build the main outline of the study. When you first open a new study the study structure will be empty. You will need to customize your structure to fit the needs of your study. A study can consist of Visits, Forms, Repeating Data structure and Repeating Data for
This article shows how to send multiple surveys to study participants. If you prefer to send surveys to an individual participant, check this article. If you haven't sent any surveys yet, this page will allow you to to create your first bulk survey invite or manage your groups to which a survey will be sent: To send surveys in bulk, you have to: C
The following PDF files include instructions for the usage of Castor EDC according to the three default user roles. You can download or print these files for your own documentation: Study admin instructions This PDF file contains manual instructions for study admins. It contains instructions for creating and testing a study, and information about ad
The following PDF files include instructions for the usage of Castor CDMS according to the three default user roles. You can download or print these files for your own documentation: Study admin instructions This PDF file contains manual instructions for study admins. It contains instructions for creating and testing a study, and information about a
Dinsdag 7 mei 2019 Aanpassingen: Bulk acties voor documenten: Het is vanaf nu mogelijk om in het Documenten tabblad bulk acties door te voeren middels de 'Bulk acties' knop. Op deze manier kan bijvoorbeeld de status van meerdere documenten in één keer aangepast worden. De volledige naam van kolomtitels worden nu zichtbaar wanneer je hier met de muis
To unlink a linked study, open your linked test or production study and follow the steps below: 1. Navigate to the Study Structure -> Form Sync tab. 2. Click 'Unlink' study button: 3. Confirm that you would like to unlink the two studies. 4. Once unlinked both studies will still be accessible from your studies overview. Removing the link bet
The following PDF files include instructions for the usage of Castor CDMS according to the three default user roles. You can download or print these files for your own documentation: Study admin instructions This PDF file contains manual instructions for study admins. It contains instructions for creating and testing a study, and information about a
Release date: 7 December 2021 ENGLISH: System defect fixes: Admin users were unable to remove approval request roles from the system. This was now fixed. The notification for inactive approval requests that were created automatically by adding a participating department, are now being triggered again. One of the ‘Save and close’ buttons in the insti
Regulations regarding the use of eConsent can vary widely across borders. Download th e whitepaper to learn the regulatory stances in various countries on use of eSignature and eConsent in clinical trials: eConsent Readiness Guide
It is possible to separate the production study and test environment automatically by using a Form Sync feature or manually creating a duplicate of a study. To learn more about creating a duplicate of your study automatically, read the article: Using Test and Production Study Environments in EDC/CDMS If you want to create a duplicate of your st
Source Data Verification (SDV) is a method used in clinical trials to ensure the data being collected is accurate. It primarily involves a comparison of the source data against its final case report form and aims to identify any errors before study closure. Your browser does not support HTML5 video. SDV Plan Capabilities In Castor CDMS, it is possib
ddCastor EDC allows you to format the text of some fields and survey intro and outro texts. To edit the survey intro formatting, go to the 'Study Structure' tab and navigate to the 'Surveys' sub-tab. The same applies when editing a survey package. To format to the intro and outro texts, use the following markdown that applies to both survey and surv
In calculations, it is sometimes necessary to repeat a certain action several times. For example, you want to calculate an average of several variables, while some of them are allowed to be empty. In this context, we would need to check each variable, calculate the total sum of the variables that are filled in, and divide it by the number of variabl
Changing a survey structure after it has been sent will modify it for all the recipients (future and present) of a survey. Deleting the fields or forms of an already sent and completed survey will lead to removal of the fields or forms and will cause data loss even if the survey has been locked. If you modify the survey package introduction text or
It is also possible to create multiple participants ID at once by importing them. First, you need to prepare your data horizontally, with the desired participant Id(s) and the site abbreviation (as set in Settings) in one of the first five columns (A-E). Importing data can only occur into participants and fields that exist in your study and hav
Yes we do. We have plenty of experience collaborating with clients for subsidies such as Horizon 2020, NHS, ZonMW, NIH and more. Contact us for more information.
Castor Connect is Castor’s mobile application, enabling participants to complete their study assessments (‘surveys’) from the comfort of their personal devices. Below is an example of how the Castor Connect app is displayed on an iOS device: As long as participants have been able to download the latest survey package, they will be able to continu
Step-by-step guide As many COVID cases are not admitted to hospital, and to further address these uncertainties, WHO invites: Member States, health facilities, research networks and individuals to contribute anonymized individual data on cases of COVID-19 to this WHO Global Platform. Please note, if you already registered on the Castor EDC platform,
Surveys are the individual questionnaires that you send to participants, which are created as forms in the Study Structure tab. Survey packages act as digital folders for your surveys, and allow you to send them to an email address. Whether a package contains a single survey form or many, surveys are always sent via packages. You can learn how to c
You can use this template to calculate the BMI of the patient. Fields needed: Height of patient in meters, variable name: height. Weight of patient in kilograms, variable name: weight. Please make sure to replace the variables weight and height with your own variables. Template to use: {weight}/({height}*{height})
eConsent 2022.x 21 CFR Part 11 Statement of Compliance is available for download below. eConsent_2022.x_21_CFR_Part_11_Assessment_of_Compliance.pdf
It is possible to make changes to the study forms after a study has been live, but the study status must be changed to "not live" before you can make adjustments to the study form. It is important to remember that existing data may be affected by changing the study forms. To make sure that the changes you make will not affect existing data, please
Security is of utmost importance at Castor EDC. Castor is officially certified in the field of Information Security (ISO 27001 – Standards for Information Security Assurance), the standard that describes how Information Security should be organised in a process-based manner in the context of the general business risks for the organisation. To find o
Release date: 7 December 2021 Added features and / or functionalities Ability to report multiple queries on same field We have introduced this functionality to allow multiple queries to be simultaneously managed by monitors on single data points (fields). Users can open more than one query on study & report fields. This is easily accomplished v
When creating or editing a field, it is possible to make it dependent on only one field. However, using hidden calculation fields, you can also create dependencies on multiple fields. For example, I want my Field_4 to be dependent on both Field_1 and Field_2 being answered with "Yes". In this case, my fields 1 and 2 are radio button fields, with
Met een Castor account kun je zowel inloggen in Castor EDC (Electronic Data Capture) als in Castor SMS (Study Management System).Heb je al een Castor account? Je kunt dan direct inloggen.Heb je nog geen Castor account? Dan dien je jezelf eerst te registreren. Registreren Castor account Ga naar de login pagina van de Castor SMS omgeving van jouw inst
Users with the ‘’Manage Users'' permissions can bulk import users in their study by creating a CSV file that they can upload. You can import up to 50 users at a time. Import users To do that follow the below steps: 1.Navigate to the ''Users'' tab 2.Click on the ''Import users'' button 3. In the window that will open, choose your file and click on '
Release date: 14 June 2021 Castor Connect Authentication (App) Users must install the application before attempting to register or activate Users receive an email from EDC with an authentication link in it. This authentication link will open the app for the specified record in EDC. The user will need to authenticate with this link a first time befor
Once two studies are linked, there are certain considerations that you need to take into account when working with the linked studies: Only users with “Manage Forms” rights can see the “Study link” option from “Study Structure” tab. This right is necessary in both the test and production study. The linked test study cannot be set to “live” and the s
It is possible to add/manage the types of data verification in the study settings. 'Source data verification' and 'Other' are provided by default, and the verification types used in the study may be changed or removed as necessary. To be able to verify forms, the user will need to have 'Verify' rights. For more information see the relevant helpdesk
Admin gebruikers kunnen voor een veld aangeven of het zichtbaar is en of de studie kan worden opgeslagen zonder dat er gegevens in het veld werden ingevoerd. In dit artikel wordt uitgelegd hoe u deze veldconfiguraties kunt beheren. Een veld verbergen In Castor SMS zijn er veel velden. Mogelijk zijn niet alle velden van toepassing, dus deze kunnen wo
Repeating Datas can be used to register data that does not fit in the standard research protocol. A repeating data can for instance be used to register adverse events or non-scheduled hospital visits. You can view these repeating datas in the repeating data tab of a participant: In this tab you see an overview of all repeating datas you have added
Het is mogelijk om gebruikers te deactiveren. Gebruikers die inactief zijn: Kunnen niet meer meer inloggen; Ontvangen geen e-mail berichten vanuit Castor SMS; Worden niet meer standaard weergegeven bij het toevoegen van een studieteamlid; Worden in het Gebruikersmenu niet meer standaard weergegeven. Waarom gebruikers deactiveren? Wanneer iemand geen
The 'Tasks' overview provides a list of tasks that are assigned to a user. Study specific tasks are also visible within the study’s ‘Tasks’ tabpage. The tasks feature consists of the following possibilities: Viewing tasks Creating new tasks (manually or automatically) Completing tasks 1. Viewing tasks: The following tasks are listed in the ‘Tasks’
Let op: Dit artikel is alleen van toepassing voor gebruikers met rechten voor het Admin tabblad. Het goedkeuren van een studie indiening: Open een studie; Ga naar het Admin tabblad; Selecteer de juiste studiestatus en klik op Opslaan. Afhankelijk van de notificatie instellingen ontvangen de contactpersonen van de studie een e-mail over deze studie g
There are several possible causes if a calculation field does not have a value: The form in which the calculation is located, has not been opened for the participant in question. Please note that you should always open the form in which the participant is located, so that its value can be updated. The calculation template might be inaccurate - check
Castor eConsent 2023.2.0.0 Release Certificate is available for download below. Castor eConsent 2023.2.0.0 Release Certificate
Manage an approval request Go to the 'Studies' tab. Open a study. Go to the 'Approval requests' tab. Open the approval request. Fill in the form. Click on 'Save' to store the response. When setting an approval request to 'Approved', a button appears that allows approvers to save and sign the approval request request immediately. Clicking the 'Save'
To create your first participant, you must have at least one form created. To start adding fields to your forms, it is necessary to create a visit and form in the study structure. To create a new participant, follow the instructions provided below: Click on the Participants (1) page Click on + New button (2). You will be prompted to select the si
Calculation fields can be used to make other fields dependent on certain values added to the grid field. For example, this template outputs 1 if the data entered into the Row one, Column 1 is 'Yes' (equals to 1): var obj = JSON.parse('{grid_variable_name}'); if (Object.values(obj[0])[0] == 1) { 1; } else { 0; } This calculation will be hidden, as we
Select a visit and form Navigate to the 'Study forms' tab. Once you have created your visits and forms, you can start adding fields to your forms. When you are in the 'Study forms' tab, you can choose the Visit and Form for which you would like to edit the Study form by selecting them from the dropdown menus, as shown below. Create a new field Onc
Please note - notifications can only be managed by system administrators. When to use approval requests An approval request can be used when a specific person or department needs to approve a study related issue, for example a lawyer, financial controller, privacy expert, project manager or head of department. Approval request options are linked to
Sometimes you may need to reference study information across the study (forms, reports or surveys). Using the following tags you can retrieve the information described below when and where it's necessary. For instance, if you want to show the institute or country in data entry, or if you want to create a dependency based on the institute or country
If you want to round numbers to an X number of decimals, you can use the templates below. Change the number after 'toFixed(' to change the number of decimals. To round up to 0 decimals, use: var num = {your_number_variable}; num.toFixed(0); To round up to 2 decimals, use: var num = {your_number_variable}; num.toFixed(2);
Castor heeft verschillende datacenters over de wereld. De data in Castor SMS wordt standaard op de Europese server opgeslagen, deze bevindt zich in Nederland.
Validate grid values Calculation fields can be used to validate values in the grid field. For example, this template validates the values entered in the first and second columns of the first row. var obj = JSON.parse('{grid_variable_name}'); if (Object.values(obj[0])[0] == 1 && Object.values(obj[0])[1] == 1) { 'The values are correct!'; } e
If you log in to Castor and can't find a study in your 'My Studies' overview, follow the guidance below to troubleshoot the cause: Account - do you have multiple Castor accounts? If so, check which account you're currently signed into. If unsure, try logging in on the other account to see if the study is listed there. Archived study - since August 2
To set your study to live, you need to insert a Billing Code in the Invoice details section of the settings of your study. Navigate to the 'Settings'-> 'Study' tab in your study Navigate to the 'Billing Information' tab within the Settings Enter your billing code and all relevant Information (e.g. Department/cost center) Click 'Save changes' If
Als admin kun je de goedkeuringsstatus van studiedocumenten en studieamendementen beheren. Overige gebruikers hebben hier geen rechten voor. Goedkeuringsstatus van een document Het "Documenten" tabblad biedt een overzicht van alle toegevoegde studiedocumenten. Als een nieuw studiedocument wordt toegevoegd dan blijft de status leeg. Een Admin kan de
Adding new users to the study allows them to access the study and applicable documents. Add user to a study: Go to the 'Studies' tab. Open the study. Go to the 'Study team' tab. Click on the 'Add user' button. Fill in the fields. Contact persons will receive email notifications on the study. Click on the 'Save' button to add the user to the study. T
Once the study is locally approved, data on study progress can be collected. There are two methods to manage study progress: Progress reports Inclusion numbers Add progress report Go to the 'Studies' tab. Open the study. Navigate to the 'Study progress' tab. Click on 'Add new progress report'. Complete the form. Click 'Save'. The progress report is
Users with ‘’Manage Settings'' rights can bulk create sites in CDMS by creating a CSV file that they can upload. Importing Sites To do that follow the below steps: 1.Navigate to the Settings>Study option 2.Click on the ''Manage sites'' button 3.Click on the ''Import files'' button 4.In the window that will open, choose your file and
Learn how to set up a Castor account to streamline and simplify data collection in CDMS. To start using Castor CDMS, you need to first create an account. This can be done completely free of charge. Register in Castor by following the steps below. You can register a Castor account in one of two ways: Using the Castor CDMS website: To register via the
The ‘Check & Submit’ tab of a study shows an overview of the required documents and fields that need to be completed before the study can be submitted. Please note that submission and approval flows can differ per institute. Submit a study Go to the 'Studies' tab. Open the study. Go to the 'Check & submit' tab. It may be necessary to complet
In this tutorial you will learn how to automatically create and send a survey invitation based on a field value updated event using the Automation Engine. Example: Schedule an SF-36 survey (Short Form Health Survey) for a patient as soon as the field "Is the patient pregnant?" is answered with "Yes" Parameters Event: Field value is updated. Conditi
Yes, it is possible to import study data with missing information. To assign data as missing before importing, you can enter the value ##USER_MISSING_99## in the appropriate cell. This will import the value -99 for this field. Replace 99 with any of the other values that are used for missing data: Measurement failed (-95) Not applicable (-96) Not as
For English see below Dinsdag 16 juni 2020 Aanpassingen: De grafiek "Totaal open aanvragen per type" in het Dashboard is aangepast. Deze grafiek laat nu het aantal goedkeuringsaanvragen zien die in de geselecteerde tijdsperiode in een status staan of hebben gestaan die gelinkt zijn aan SMS status ‘Open’. Taken: Bij het toevoegen van een gebruiker aa
To be able to store encrypted data, you need to encrypt the fields where these data belongs. For example, if you are storing date of birth, this date field will need to be encrypted. Field types that can be encrypted Encryption is allowed for Study and Repeating fields of the following types: Number, Radio button, Dropdown, Checkbox, Date, Year, Tim
Your browser does not support HTML5 video. A study admin can invite you to participate in the study by sending an invitation. You will receive an invitation by email for the study for which you need to do data entry. If you do not already have an existing account on the study's server then you will be required to create a new account. Addition
This tutorial covers the functions you can use to calculate with multiple fields, even if one or more of the values are not set. The tag '##allowempty##' tells Castor to allow for empty fields to be used in a calculation. '##allowempty##'; Empty fields normally are stored as 'NA' (which means Not Available). The tag '##setemptytozero##' sets these
How do I get started? Complete survey using Castor Connect If you are using the Castor Connect App, after clicking your survey link, it may also redirect you to download the Castor Connect app. Please download the app. Once the app is installed, please use the link in the survey email to complete the registration and access the currently available
Some studies contain long lists of options, for example countries or medication lists which are often used as dropdown menus. In this case it is best to upload the option group in Castor. Before you start Before importing an option group, it's important to make sure that the csv file is formatted properly. Option groups with up to 15000 options can
SAS is a software suite used for advanced analytics, data management, and statistical analysis. Castor EDC allows you to export collected study data into two SAS-compatible formats: XPT or 7BDAT. Note that the 7BDAT files are generated on a 64-bit Linux machine. This feature is available at no additional cost but must be enabled on a per-study bas
When setting a study to 'Live' for the first time, you will be offered the option to reset the study's randomization. This means that if you have set up randomization in your study and have randomized test participants, you can reset the study's randomization and the test participants you have randomized will not affect the randomization of your pat
One of the messages that we might frequently see in our calculations is "Not all values for this calculation are available (yet)" (see Calculation errors ). The message indicates that not all fields that are used in the calculation contain values. It can be inconvenient to see it on screen, especially in surveys. In this article we explain how you c
With this calculation template, you can check whether a group of fields have been filled in or are empty. If certain fields are not filled in, they will be listed in the calculation. In this example, the fields "Gender", "Year of Birth" and "Pregnancy" are checked. Replace the field labels and variable names in the second and third line of the calcu
Wat is een offerte aanvraag? Studies kunnen gebruik maken van een deelnemende/ondersteunende afdeling. Deze kunnen toegevoegd worden aan een studie. De deelnemende afdelingen zijn gekoppeld aan een gebruikersrol die Admins beheren. Het kan zijn dat meerdere gebruikers in het systeem dezelfde rol hebben. Zodra een offerte aanvraag (envelop icoon) voo
Monitors and monitor visits can be managed at study level. Monitor tab You can manage the monitors and monitors visit on the monitor tab within the study. Please note that normally the monitor tab is not available for a study. In order to enable it you need to go to "Review process" tab and set "Yes" in the "Is there monitoring?" field. After that
It is possible to set up an automated reminder when creating/editing survey package. This is a generic setting for the survey package and will always be applied when an invitation is sent for that survey package. Learn how to set up an automated survey reminder here.
With our R package you can easily retrieve your Castor data in real time. You can use the data to create dashboards with R, RStudio, and Shiny. In this article we will give you steps to get started. Installing R and RStudio Install R from https://www.r-project.org/ Install RStudio from https://rstudio.com/products/rstudio/download/ Retrieve Castor d
Bij multicenter studies kunnen de deelnemende centra geregistreerd worden. Dit kan alleen indien de studie is aangemerkt als "Multicenter, verrichtend centrum". Toevoegen deelnemend centrum: Ga naar het Studies menu; Open de studie; Ga naar het Deelnemende centra tabblad; Klik op de Toevoegen deelnemend centrum knop; Vul het formulier in; Klik op de
Your browser does not support HTML5 video. Responding to queries If a monitor has placed a query on a participant, this query icon appears on the participant list in the Queries column. Clicking on the query icon will take the user to the field in which the query was placed. Once a user clicks on the query icon from the field, the query stat
Your browser does not support HTML5 video. The Study Dashboard allows to track the progress of your study, including: Participant recruitment Data collection progress Randomization Queries Please note that the data aggregated in the dashboard is based on your viewing permissions. Users can see the Dashboard page, only if they have the "Participan
Het Studies menu geeft een overzicht van jouw studies. Dit menu bestaat uit 3 tabbladen: Alle studies (A), Favoriete studies (B) en Laatst geopende studies (C). A. Alle studies: Hier worden alle studies getoond waar jij toegang tot hebt. Weergave: Horizontale scrollbar: De breedte van de kolommen in het "Alle studies" tabblad wordt aangepast aan de
This article details how to unlock a user account. In Castor, an account is locked when the user enters a wrong password 10 times. Locked users If a user has tried to log in more than 10 times using a wrong password, Castor will lock the account and prohibit access until the account is manually unlocked. Note: The count of 10 incorrect entries ac
At least two times a day all eCRF's in Castor CDMS are backed up. The daily backups are retained for 28 days. The monthly back up files are kept for one year. Reserve copies can be restored but this might add additional costs. You can also back-up your eCRF forms and data yourself by exporting the data and store it on your computer. Please consul
We’ve provided an overview of the measures we take to secure your data in our Security statement: If anything unexpected should happen to our company we want to minimize the impact this has for our clients. Therefore we provide coverage on the short and long term: Short term coverage through a continuity solution: we have deposited funds in a sepa
In the calculation you can give a 'score' based on the value of a different field. In the template below, the calculation field value will be 1 if variable_x is in between 1% and 19%, 2 if variable_x is in between 20% and 39%, etc: If variable_x is... The score is... In between 1% and 19% (incl. 1 and 19) 1 In between 20% and 39% 2 In between 40%
Andere gebruikers kunne toegang krijgen tot de studie door hen toe te voegen aan het studieteam. Het toevoegen van een gebruiker Ga naar het Studies menu; Open de studie; Ga naar het Studie team tabblad; Klik op "Voeg een gebruiker toe"; Vul het formulier in; Voeg een bestaande gebruiker toe of een nieuwe gebruiker middels het e-mailadres Selecteer
Study structures can be exported to XML format from an existing study and imported directly into a new study. Learn more on how to export and import the study or form structure in the article: Export and import the form structure in EDC/CDMS The Castor Form Exchange can be a useful resource for study admins - researchers using Castor are able to s
Following the basics described in Calculate with grid fields , the current article explains how to calculate with grids when the cells have been defined as "date". Once again, the first step is to parse the JSON string. Although not necessary, it may be helpful to then put each date in a variable and then work with them in our calculation. Here, we
Castor eConsent enables researchers and organizations to create and manage electronic informed consent forms for their studies. Before you can start using eConsent, you will need to be granted access and have an admin account created for you. This video and the article will guide you through the necessary steps to get started with Castor eConsen
Release date: 14 June 2021 Castor Connect Authentication (App) Users must install the application before attempting to register or activate Users receive an email from EDC with an authentication link in it. This authentication link will open the app for the specified record in EDC. The user will need to authenticate with this link a first time befor
Learn how to safely and efficiently merge changes from a test environment to a production environment in CDMS in the article below. Final changes are always applied from the test to production study, never the other way around. Once the changes are applied to the production environment, it is no longer possible to revert them. To remove any changes
Castor EDC/CDMS user interface is only available in English. However, you can build your study forms and surveys in any language. You can read more about building your study forms and surveys in multiple languages in these articles: How to build study forms in multiple languages in EDC/CDMS How to build surveys in multiple languages in EDC/CDMS
The Audit Trail shows all changes that are made to your study. This includes changes both during building the form and during data entry. The Audit Trail will be visible if a study team member has all management rights Your browser does not support HTML5 video. The Audit Trail The audit trail enables you to review changes to study settings and study
The dashboard provides a quick and simple overview. The dashboard provides two views: Approval requests Amendments Please note: Access to the dashboard views is depending on your user rights. User rights are managed by system Admins or your organisation. General dashboard functionalities Go to the 'Dashboard' menu. Select a view. Select a time windo
Yes - Castor offers a randomization module which uses validated variable, weighted block randomization with the ability to include stratification using fields in your study forms. Learn more about randomization algorithm and how to set randomization for your study in the section Randomization
All data is stored on servers hosted by certified hosting party. Certificates are available on request. Backups are made twice per day and moved to a separate geographic location daily. See our Security Statement for more information. Microsoft Azure: Europe, Australia, United Kingdom, United States, private clusters ISO 27001 certified ISO 9001 c
Before merging the changes to the production environment, it is possible to download a full backup of the production study. The full backup includes a copy of the study structure and the study data for all participant records. The option ‘Download backup’ is only available for users with full Institute rights, including view randomization, decry
The automation engine allows you to hide visits when they are not necessary - if a condition is met, the visit will be hidden. All visits are shown by default. If the field value is changed and the condition is no longer met, the visit is shown again. Dependencies can be used to only show certain study fields when a condition is met, but a dependen
Time fields in Castor only capture hours and minutes. If you would like to capture time in the format hh:mm:ss, you will need to use text fields. However, you can calculate with those as well. To calculate the difference in time between two text fields that use hh:mm:ss, you can use the following template. The output will give the time difference
If you have lost or forgotten your password you can reset it following the below two steps: Type your email address to the server your account belongs 2. After that you will be redirected to enter your password. There you can click on the ‘’Forgot password?'' button After clicking on the link, you will be prompted to enter your email address.
For English see below Donderdag 28 januari 2021 Aanpassingen: Goedkeuringsaanvragen: De "Indienen & Opslaan" knop is nu altijd gedeactiveerd voor gebruikers met een Admin rol en een rol die gelinkt is aan een goedkeuringsaanvraag. Hierdoor wordt voorkomen dat een goedkeuringsaanvraag weer opnieuw wordt ingediend terwijl deze eigenlijk op een and
Dinsdag 19 maart 2019 Aanpassingen: Amendementen: Vanaf nu kan elk type document toegevoegd worden aan een amendement. Dit gebeurd middels dezelfde workflow als in het Documenten tabblad. De documenten die worden toegevoegd via een amendement komen in het Documenten tabblad van de studie terecht. In de e-mail notificatie is een nieuwe variabele toeg
For English see below Woensdag 6 mei 2020 Aanpassingen: Goedkeuringsaanvragen: Alle goedkeuringsaanvraag statussen zijn nu gelinkt aan interne SMS statussen. Dit maakt het mogelijk om voor elke SMS omgeving andere statussen in te stellen voor de goedkeuringsaanvragen, terwijl de gerelateerde automatische notificaties en dashboard blijven werken. Dit
This article provides guidance on selecting the data storage options for Castor CDMS. On the Login screen, you can select which server you want to access. Castor CDMS has a separate database within each stand-alone region. Our US server is in the Americas (US) region, our NL and UK servers are in the European (EU) region and our AU server is in Aus
Dinsdag 2 april 2019 Aanpassingen: Amendementen tabblad van een studie: De datum goedkeuring toetsende commissie (METC/CCMO) is vanaf nu ook aanpasbaar voor niet-Admins; Een nieuw veld om de datum van de lokale goedkeuring in te tonen is toegevoegd. Dit veld kan alleen door een Admin ingevuld worden; De status "Afgekeurd" is toegevoegd. Amendementen
Once you have selected the event that will trigger the automation, you can add conditions to the automation. These conditions will be checked by the system in order for the action to be triggered. For example, you want to add a query only when the field value is updated such that the participant weight is greater than 150 kg, or you want to only sen
Dinsdag 17 september 2019 Aanpassingen: Documenten: Het definitief verwijderen van studiedocumenten kon eerst alleen één voor één. Nu is hier een bulk actie voor toegevoegd waardoor meerdere studiedocumenten in één keer definitief verwijderd kunnen worden. Als voorbereiding op de integratie met Castor EDC wordt het 'Studie voortgang' tabblad nu ook
Release date: 12 January 2022 ENGLISH: System defect fixes: While it was possible to assign monitor delete rights, there was no action available in the monitor tab to remove a monitor. This has now been added, so users with monitor delete rights can delete a monitor. In some cases, when trying to delete a department from the institutes tab, the syst
In the 'Study Structure' tab, it is possible to copy entire forms, including all fields that are within the selected form. More information on how to do this can be found in the article: Copying forms. When copying forms, you have the ability to choose where in the study to copy to. It is possible to 'cross-copy' forms between study, repeating data,
The ‘Users’ tab is where all user rights and roles are managed. Any individual who needs to access a part of the study must be added to the study as a user using their email address. In previous releases, individual user rights were defined on site level, but in the 2023.4.1.0 release, we will no longer support setting rights at the user level; In
If you want to set subject status on your study you can do it by using the participant Status feature. If you want to learn how to create participant status, please visit The Participant Status article. It is also recommended that an “End of Study” visit be built into your study. Here, you can collect study completion information: If a subje
Castor SMS 2021.8 release certificate. Release notes for 2021.8 can be found here. SMS_Release_certificate_2021.8_Signed.pdf
After a Repeating Data structure has been created, you can use the repeating data button to allow users to quickly access a repeating data form from your CRF. You can add a field in your study forms that will display a button which can quickly add a specific repeating data form during data entry. The repeating data form is automatically linked to
Do you want to contact us? You can send us an email to support@castoredc.com Or you can contact us using the button at the bottom-right corner of this website. During business hours (weekdays from 9:00am – 2:00am CET/CEST and from 3:00am – 8:00pm EST/EDT (excluding regional holidays)) you can speak with a Support Agent in it. For phone support, you
You can register a Castor account to start exploring the system right away. You can create a test or demo study for free and check the system from your side. You can also request a personal Castor EDC/CDMS demonstration - just complete the request form and a member of the team will contact you to arrange a demo. Our Professional services team ca
We have found that very little support and/or training is required both for constructing the eCRF and for the data entry. Through Castor Academy, we provide role-based courses to get acquainted with the system. We also offer customized training on-demand if you require this, please contact us.
Woensdag 12 december 2018 Aanpassingen: In het Taken menu kan je vanuit de geopende taak direct naar de gerelateerde studie gaan middels de nieuwe "Open studie" knop. De e-mail die verstuurd wordt bij het handmatig aanmaken van een taak biedt nu de link naar de gerelateerde studie, in plaats van altijd een link naar de algemene Castor SMS omgeving.
Dinsdag 26 november 2019 In deze release zijn alleen technische verbeteringen verwerkt die niet direct zichtbaar zijn voor gebruikers. Tuesday 26th of November, 2019 Only technical improvements are implemented in this version, there are no functional changes for users.
An event is a data entry point within your study that will be checked by the system against the conditions you specify and trigger a certain action when the two match. Add an event After you navigate to the Automation Engine user interface, click on the "Event" button: Define your event An popup dialog will appear. This is where you can define your
What happened? You have previously entered data in a grid field and now you can no longer see it. Adding new data also doesn't save. What is the reason? If you are experiencing problems with saving data in grid fields, the most likely reason is that you have changed the grid field configuration after data was entered. For example, you might have ad
Each time you access a web page through your web browser (Internet Explorer, Firefox, Chrome, etc), the browser caches (i.e., stores) it, so it doesn't have to keep retrieving the same files or images from the remote web site each time you click Back or Forward. If you experience any slowness or issues, it might help to clear the cookies and cache f
Woensdag 5 september Technische aanpassingen: De individuele Castor SMS omgevingen zijn nu technisch gezien samengevoegd op één omgeving. Hierdoor kunnen wij makkelijker en sneller systeemupdates doorvoeren en de manier van programmeren is efficiënter. Een aantal veiligheidsverbeteringen zijn doorgevoerd. De labels van de velden zijn snel aan de te
The Study Design and Study Forms builder in Castor CDMS allows you to create and customize your electronic Case Report Form (eCRF). Castor CDMS organizes study into four main components: Visits, Repeating Data, Surveys, and Survey Packages. Visits Visits and forms make up the primary Case Report Form (CRF). When a participant is created, all the Vis
Free Castor studies are aimed at researchers searching for an alternative to managing data in Excel spreadsheets. A study is free of charge if it is conducted within one research institute for a maximum of 12 months and has up to 125 inclusions. For commercial users or those with studies that don't meet the stated criteria, you can generate an estim
The following PDF files include instructions for the usage of Castor EDC according to the three default user roles. You can download or print these files for your own documentation: Study admin instructions This PDF file contains manual instructions for study admins. It contains instructions for creating and testing a study, and information about ad
The following PDF files include instructions for the usage of Castor EDC according to the three default user roles. You can download or print these files for your own documentation: Study admin instructions This PDF file contains manual instructions for study admins. It contains instructions for creating and testing a study, and information about ad
Grid fields are used to group closely related data in a tight interface (table). To create a grid field, in 'Study form' > 'Visits' select field type 'Grid' from the list of field types. The 'Add a new field' dialog window will appear: Choose the position, add a label and name the variable. Once completed, click 'Set configuration' to
Users with the ‘Study Investigator’ or ‘Study Monitor’ role are able to generate an export of signature information. To export the signature information, follow the steps below: 1. In the ‘Participants’ overview, click on the ‘Export’ button: 2. In the ‘Generate export file’ pop-up window, in the ‘Export type’, select ‘Consent form information
On this page you can share forms and calculations that you have made in Castor EDC/CDMS. You can find a lot of predefined form or calculations in our Form Exchange, or provide your own for others to use. We hope that our users will share what they have created and feel may be useful for other Castor users too. 1. Login to the Castor Form Exchange Yo
This article contains solutions to the most common error messages and issues when using the Castor EDC R Package . Keep packages updates As a general concept it is important to note that R packages get updates separately. It is thus possible to have out-of-date packages installed that will impact the functioning of other packages. To avoid issues d
It is not possible to use Repeating Data structure or repeated measures in surveys. Please consider the following alternatives for Repeating Data/repeated measures in surveys: Using grid fields Create a grid field to collect measurements. You could add a radio button and an additional grid field in case more measurements are required. Make the addit
For English see below Woensdag 5 mei 2021 Bug fixes: Wanneer een user werd toegevoegd aan het studieteam als Administratief medewerker, dan werd zijn/haar CV (wanneer geüpload in het profiel) toegevoegd aan documenten. Echter, dit moet alleen gebeuren wanneer de user wordt toegevoegd als Hoofdonderzoeker. Dit is nu opgelost. Wednesday May 5th, 2021
For English see below Woensdag 15 juli 2020 Aanpassingen: Bij de deelnemende centra is het nu mogelijk om een studiespecifiek contactpersoon toe te voegen. Tevens is de algemene contactinformatie inzichtelijk. Elektronische handtekening: Bij het ondertekenen van een goedkeuringsaanvraag wordt om een reden gevraagd.Na ondertekening wordt de reden ook
Het dashboard geeft een eenvoudig en snel overzicht. Het dashboard biedt twee weergaven: Goedkeuringsaanvragen Amendementen Let op: de toegang tot de weergaven in het dashboard is afhankelijk van je gebruikersrechten. Gebruikersrechten worden door Admin gebruikers beheerd. Algemene functionaliteiten van het Dashboard Ga naar het 'Dashboard' menu. S
For English see below Dinsdag 5 april 2020 Aanpassingen: Een snelheidsverbetering is doorgevoerd waardoor het laden van de studies veel sneller gaat. Bij de studiestatus "On hold" kan een reden hiervoor aangegeven worden. (Op deze manier is het mogelijk om bijvoorbeeld een onderscheid te maken tussen de studies die on hold zijn gegaan wegens het cor
Dinsdag 27 november 2018 Aanpassingen: Toevoegen nieuwe gebruikers: Voorheen konden nieuwe gebruikers alleen toegevoegd worden aan Castor SMS via een studie. Niet alle gebruikers in Castor SMS zijn gerelateerd aan een studie. Daarom is het vanaf nu ook mogelijk gebruikers toe te voegen aan Castor SMS vanuit het Gebruikers menu, lees hier voor meer u
Dinsdag 16 oktober 2018, versie 2018.18 Aanpassingen: Goedkeuringsaanvragen: Twee nieuwe velden zijn toegevoegd: "Informatie over deze goedkeuringsaanvraag": Bij het toevoegen van de goedkeuringsaanvraag kunnen hier opmerkingen/notities in geplaatst worden over de goedkeuringsaanvraag. Tevens kan dit veld getoond worden in de goedkeuringsaanvragen g
Introduction: Use these prompts with our new AI calculation helper! Tips and tricks: Be specific! Specify the name and type of your fields if you can, e.g. “…for v1_pat_weight (number) ….” or “…. for pat_gender (radiobutton) …." Explain what you are trying to do like you are writing to a human! The max input length is set to 200 characters, for saf
Dinsdag 7 augustus 2018 Aanpassingen: De iconen in het hele systeem hebben een aanpassing gekregen. Het uiterlijk van het algemene menu is ook aangepast waardoor dit er aantrekkelijker uitziet (links is de oude situatie en rechts is de nieuwe situatie). In de vorige systeemupdate is het Controle en indienen tabblad van een studie volledig omhoog ver
After logging in, the “Studies” overview will be displayed. The overview will show the list of the studies to which you have been invited to participate. Studies overview consists of the following elements: Servers: Here the data storage locations are displayed. There are two server locations available: Europe and the United States. Study data
Dinsdag 20 augustus 2019 Aanpassingen: Audit trail: Wanneer in één keer alle studiedocumenten worden gedownload wordt dit nu ook weergegeven in de audit trail. Ook de documenten die worden gedownload vanuit een gebruiker (GCP/BROK certificaat of cv) worden vanaf nu geregistreerd in de audit trail. Een nieuw audit trail gebeurtenis is toegevoegd wann
You or your data suppliers are and will remain the owner of the data which you process with our services. Please consult our Terms of use for full information. If you choose to publish forms via the Castor Form Exchange, you explicitly consent that other users can download and use them.
Time difference between two time fields on the same day To calculate the difference between two time fields in hours, minutes, or seconds, use the following formula: getTimeDiff('{time_variable_2}', '{time_variable_1}', 'm'); where time_variable_1 is the first time point (time field) and time_variable_2 is the second time point. Replace these with y
Dinsdag 6 februari 2018 Aanpassingen: De Audit trail is vanaf nu zichtbaar voor gebruikers met een Admin rol. In het Audit trail menu worden alle aanpassingen in het systeem weergegeven. In het Audit trail tabblad van een studie worden de aanpassingen van de betreffende studie weergegeven. In dit artikel wordt de Audit trail besproken. Er is een ver
Dinsdag 22 januari 2019, versie 2019.2 Aanpassingen: Audit trail: Het openen van een studie wordt vanaf nu ook gelogd in de audit trail, onder gebeurtenis type "Studie geopend". Admin tabblad van een studie: Bij het aanpassen van de studiestatus in bijvoorbeeld "Goedgekeurd door RvB" wordt automatisch de datum van vandaag ingevuld in het corresponde
Text and multiline text fields The maximum length for text field and multiline text field is 4196 characters: Maximum number of characters for option groups Option group name 50 Option group description 50 Option value 1024 Option name 1024 Maximum number of characters in field characteristics Field label 1024 Field variable name 64 Field units (if
For English see below Woensdag 29 juli 2020 Aanpassingen: Documenttype "K. Monitorrapport" is toegevoegd aan de Nederlandse documentenstructuur (CCMO). Templates voor brieven functionaliteit: Bestandsformat .rtf wordt niet meer ondersteund Variabele AVG nummer is toegevoegd en kan gebruikt worden middels ${studyGdprNumber} Wednesday July 29th, 2020
Data entry in Castor is simple to do. You will need access to the study before you can view participants and enter data. For guidance on performing data entry in Castor, see the helpdesk article - Doing data entry
Dinsdag 15 oktober 2019 Aanpassingen: Optie "DCRF" is toegevoegd in de optiegroep met toetsende commissies; Veld "Site ID/nummer" is toegevoegd in het tabblad voor 'Deelnemende centra'. Bug fixes: De lijst met actieve documenten bij het downloaden van een template wordt weer in de juiste styling (lettertype, grootte) weergegeven; Optiegroep "Risicoc
You can search for participants that contain certain data, for example if you want to find all patients of a certain age or gender. Click on the arrow in the left search box and find the field (question) of interest. In this example ‘Gender’ is selected. Enter the value of interest in the right search box (in this example "female") and all relev
We’ve provided an overview of the measures we take to secure your data. See the security statement also here . Integrity and honesty are the key attributes of everything we do at Castor. We are committed to protecting our customers’ data above all else. Castor is secured according to the most recent standards in order to protect your data in the
The encryption module allows the secure storage of personal data of study participants such as date of birth, name etc. This module allows individual Castor fields (study variables) to be stored in an encrypted manner. This means that the data is stored in the database in the form of a random code. To view the data that lies behind this code, the us
You can copy forms in the study structure, the repeating data structure and the survey structure. To copy a form, follow the steps: Go to Study Structure While on the Visit Tab, hover over the visit/form which you want to copy From the kebab menu (the three dots) Click ‘Copy form’. Enter all of the details, as needed. Copy to: Choose to which st
Castor eConsent 2021.3 release certificate is available for download below. eConsent_v2021.3_Release_Certificate.pdf
It is possible to deactivate users in SMS. Users that are inactive: Will not be able to log in Will not receive e-mail messages from Castor SMS Are no longer visible when adding a study member to a study team Are no longer shown in the user menu, only when filtered on 'inactive' Why deactivate users? When someone shouldn't have access to Castor SMS
The 'Monitoring' tab gives an overview of all the queries, data validations and dropped verifications in a study. To enable monitoring for your study, follow these steps: Go to the study 'Settings' Navigate to the Study properties tab Check the box next to the 'Monitoring' option Save the change Once enabled in the study, users with the ‘View’
Now that you have completed building your study, it is time for User Acceptance Testing. User Acceptance Testing, or UAT, is one element of your validation process. UAT should test for both positive and negative results and you should begin with a plan for what and how you will test each field. Before starting UAT, we recommend that you perform
Roles are in essence a set of rights that can be defined per user per site. Roles in Castor CDMS have a two-fold purpose: You can easily assign the appropriate rights for a certain user. For example, instead of selecting each right for a user that needs all rights for a site, you can assign them the role 'Admin' - this will select all rights im
"Going live" in essence means that your study is 'in progress' and you can start collecting data. When the study is not live only users with at least one management right can access it. Once live, users you have invited to your study will be able to access it, depending on their respective assigned rights. Here you can learn how to set your study
All study settings can be found in the tab 'Settings', subtab 'Study'. This tab is available for the study admins with 'Manage Settings' rights. Here we describe all the settings that you can adjust. Your browser does not support HTML5 video. General settings Here you will find the following details: Study name: Change the study name which is displa
You can use the following templates to calculate the BSA of a subject using their height and weight data. These fields should exist in the study: Height of patient in cm, variable name: height Weight of patient in kg, variable name: weight Template for the Mosteller calculation: var bsa = Math.sqrt((({pat_height}*{pat_weight})/3600)) bsa; Te
This article explains how to add new consent forms, edit or delete existing ones. Adding a new consent form 1. Click on the ‘Add consent form’ button. 2. You will be taken to the ‘Consent form setup’ page to specify the details of the new consent form: Document name: title of a consent form Country: country(ies) to which a form can be link
The average of a set of numeric field values is calculated by adding up all values and dividing the result by the number of values we have: average = (value 1 + value 2 + value n) / n See also how you can calculate the median. As simple as this seems, it can be a bit more difficult to calculate it when we do not know how many values we will have in
With this formula you can calculate the glomerular filtration rate (GFR) using the MDRD study equation: var age = getDateDiff('{DOV}','{DOB}','y'); var eGFR= 186 * Math.pow(({creatinine}/88.4),-1.154) * Math.pow(age,-0.203); if({sex} == 0) { eGFR = eGFR * 0.742; }; eGFR; In this formula the following variables are used: DOV = date of visit DOB =
Your browser does not support HTML5 video. When setting up a multicenter study, new sites can be added via the 'Settings' tab in the study. To add a new site, follow the steps below: 1. Click on the 'Manage sites' button. A a page ‘Manage sites’ will be opened, which contains a list of all existing sites: 2. New sites can be created using the
For English see below Dinsdag 28 januari 2020 Aanpassingen: Dashboard menu: In de weergave voor amendementen is een nieuwe grafiek toegevoegd Gemiddelde tijd openstaande amendementen. Tuesday 28th of January 2020 Changes: Dashboard menu: Graph Average time pending amendments is added in the amendments view.
It is possible to randomize test participants in your study without influencing the data you will collect once the study is live. You can add and test the randomization in your study before it goes live - it is possible to randomize your test participant(s) to check if the randomization settings you have chosen are working correctly without concer
In this article we will show you how to electronically sign and lock a visit or form in a study or a repeating data form. Please note that in order to sign a visit or form, you need the "Sign" right assigned to you and to lock, you need the "Lock" right assigned to you. It is possible to sign off all visible (according to the user's role) forms, v
Aanpassingen : De Afdelingen zijn nu verplaatst in het Instituten menu. In het Studieteam tabblad is de rol "Apotheker" toegevoegd. In het Goedkeuringsaanvragen tabblad is een datumveld toegevoegd om te registreren wanneer een goedkeuringsaanvraag is afgekeurd. Dit is nodig om te kunnen berekenen hoelang goedkeuringsaanvragen open staan.
For performance reasons import cannot contain more than 25000 data points (rows * columns). If you would like to import the data set which contains more than 25000 data points, there are several options: Split the dataset in several parts that contain less than 25000 data points and import each part separately. More information about importing data
Your browser does not support HTML5 video. File types Participant data can be exported from Castor CDMS in the following formats: Excel CSV SPSS SAS (XPT or 7BDAT) Exporting in this file type can be enabled upon request CDISC ODM Exporting in this file type can be enabled upon request SAS and CDISC ODM exports are currently available upon customer r
When you click on the ‘Actions’ button in the Participants tab and choose the option ‘Export all’ or ‘Export selected’, you will be able to get an overview of all the variables used in your study, including option groups and dependencies. A separate variable list will be created for a study, repeating data and surveys. When exporting data to Exce
Once a Castor eConsent study has been created both study team members (Users) and Subjects can be invited to join the study, register, and gain access. The below article will describe the steps to register and gain access for Study team members and Subjects. Study team member registration and eConsent access. When a study team member is added to
Here you will learn how to import data, either per participant or for multiple participants at a time. If you are looking to import repeating data, check the article: Import repeating data. Before you start Here are some things to check before you begin this process: The variables must already exist in your study and must have assigned variable n
Your browser does not support HTML5 video. This article explains how to create your first study within Castor. To quickly become a Castor Pro, supplement your learning with our 1-hour Castor workshop . You can immediately start building your study structure and simulate data entry for free. Register and Login First, login to Castor EDC . If yo
After logging into the CDMS, you will be redirected to the ‘My Studies’ list. Here you will see the list of all the studies you have created or been invited to. Open a study for management To open your study for management you need to have at least one of the ‘Manage’ rights . On the ‘My Studies’ page click on the study row to access a study: The
Upon inquiry and in emergency situations, we can restore a back-up of a study. Doing this may lead to additional fees in certain cases. To request a back-up recovery, please contact support@castoredc.com and include the following details: Reason the back-up should be made The title of the study The closest date and time point that the recovery sho
Op maandag 27 november wordt Castor SMS versie 1.4 gereleased. Toevoegingen & aanpassingen In de kolom “Geneesmiddelenonderzoek” van het algemene Studiesmenu wordt nu ook een “Nee” getoond als het een ander type interventiestudie is. Voorheen bleef de kolom blanco als het om ander type interventiestudie ging. De koptekst van het bewerk studie ve
The Large File Upload upgrade allows the upload of large files up to 2GB on the Castor CDMS platform. By adding this feature, the maximum file upload size will be upgraded from the standard limit of 5MB to 2GB per file. The increased file size is designed for studies that require the upload of large files, including: Medical imaging, including X-Ray
Yes, the system is compliant with ICH-GCP and fully complies with all the regulations required by FDA 21 CFR Part 11 for electronic data management.
Repeated measurements are a small set of related data points that semantically belong together and that are measured from 0 to N times. A good example is repetitive measurement of blood pressure, which can consist of several related data points that are always measured/registered together. For example, you could use a repeated measure field if yo
This article explains how to create multilingual study forms. Study Forms can be built in any language. Castor CDMS supports UTF-8 format and double byte characters. The Castor CDMS core software (e.g interface, navigation buttons) is always in English, however you can build your eCRFs in any language. First of all, you will need to create trans
Castor CDMS 2025.1 Release Certificate is available below. Castor CDMS 2025.1 Release Certificate
Sometimes you need to convert the units of a given measure to keep a unified format across your study. These conversions are usually inches or feet to centimetres and pounds to kilograms, or vice-versa. In all these cases, we can use a simple operation to get it done. See some examples below: inches to cm var cent = {your_variable_in_inches} * 2.54;
At the moment, it is not possible to automatically send a second survey after a first one is completed. The Automation engine provides a workaround to help you perform this action. The following steps will be required to do so: 1. Create a checkbox field or any other option group field that allows you to manually set the status of the first survey
Testing a survey intended for web browser Once you have created a survey and a test participant, you can try to send an email with the survey to yourself, by adding your own email address to a participant. You will then get the exact email that a normal participant of the study will get: Clicking on the link will take you directly to the survey. If
Dit artikel behandelt een aantal basis functionaliteiten van Castor SMS. Persoonlijk menu:Open het menu door op het pijltje naast je gebruikersnaam te klikken. Taalinstellingen: Klik op deze knop om de taalinstellingen aan te passen. Castor SMS kan in het Nederlands als in het Engels weergegeven worden. Handleiding: Klik op deze knop om naar de supp
In some cases you might want to prevent the randomization of certain participants. This can be participants that are not eligible for randomization or for studies where only a subset of the patients is being randomized. While it is not possible to hide the randomization tab for certain participants, you can make use of the fact that all strata fie
Castor EDC/CDMS is a web-based application, and in most environments will not be affected by local firewalls. If you are concerned about Castor's compatibility with your local firewall, please contact the Castor Support team.
Your browser does not support HTML5 video. Print a single participant Please note that to print participant data, both view and edit rights are required. It is possible to print out the complete data for a participant in Castor. Open the 'Participants' tab Click on the three dots next to a participant Select 'Print': The print dialog will open and
Main features & improvements Release date: 1 March 2021 Records overview : Enhanced user experience with modern, more intuitive and easy to use elements including: Improved responsiveness for mobile and tablet devices More columns visible at once for greater information density at a glance. The number of applied filters persists on the overview
The following PDF files include instructions for the usage of Castor EDC according to the three default user roles. You can download or print these files for your own documentation: Study admin instructions This PDF file contains manual instructions for study admins. It contains instructions for creating and testing a study, and information about ad
Release date: 12 Feb 2020 Main features & improvements Notifications The notifications functionality has been extended, it is now possible to set up report specific notifications instead of a notification that is triggered for all reports that are created. When selecting new report added to a record, choose from the dropdown menu which is the sp
All survey invitations that have been created and sent in the study appear in the 'Surveys' tab, where each row represent a separate survey invitation and contains several categories (columns). You can make use of this tab to manage sent surveys. 1) You can sort the surveys in ascending (one click) or descending (two clicks) order by clicking on an
Het indienen van een studie, bij bijvoorbeeld het wetenschapsbureau of raad van bestuur, gaat middels het tabblad "Controle en indienen". Hier wordt de huidige status van de studie weergegeven en welke verplichte velden en documenten aangevuld moeten worden. Het indienen van een studie voor lokale goedkeuring: Ga naar het Studies menu; Open de studi
To hand study ownership to another user, you should first update the user rights to ensure their access level is equivalent to the study admin. Normally this requires granting all the Management rights. Once all user rights have been updated, you can edit the 'main contact' information in the Settings tab. If you no longer intend to participate i
You can use keyboard shortcuts to navigate through different tabs in Castor CDMS and to open/close dialog windows. Use Alt + ? (in Windows) or Option + ? (On a Mac) to display all available keyboard shortcuts: Windows keyboard shortcuts Use Ctrl + Alt + > and Ctrl + Alt + < to navigate between different tabs (Participants, Study structure,
Large File Upload increases the size of files that can be uploaded to Castor via the 'Upload File' field - from 5MB to 2GB per file. Currently, this premium feature can only be added to a study upon request - please contact the Castor team to find out more.
Using calculation fields, it is possible to check if the number that is entered in a numerical field corresponds to a certain format. For example, you can check if a number contains 3 digits or if it contains 2 decimals. Format 000 This template will check how many digits a number contains: '{number_variable}'.length Set up a data validation in ca
If you want to repetitively send a survey at certain intervals, for example if you want to send the same survey every month, you will need to create a survey schedule. Create a survey schedule From the 'Survey Packages' sub-tab in 'Study structure', click on 'Configure schedules': The Survey Schedule Management dialog will open where you can add
In Castor, almost all actions performed by users are tracked. It is possible to review what each user did in any field. In the participant data entry view, clicking the cogwheel next to the field and selecting 'History' opens a window displaying all data entry for that field, including the name of the user who performed the action, when the action
Admin users can tell for each field whether it should be visible and if the study can be saved without having data entered in the field. This article will explain how to manage these field configurations. Hiding a field In Castor SMS, a lot of fields exist. Not all fields might be applicable for your site, so these could be hidden to avoid having
The "Manage Encryption" right The Manage encryption right will allow you to assign "Encrypt" rights to other users in your study (see below). This is similar to the "Manage Users" right, except it is dedicated to the user rights for encrypted data. Note: At the moment, this right is also necessary to define fields as encrypted in the form builder.
Dual data entry is done by creating duplicates of each form in the CRF and assigning separate roles to the two users who will complete the data entry. This is done to ensure they can only see their assigned forms - more information on the method for this can be found here. You may also wish to use calculation fields to check for discrepancies betwee
Dinsdag 2 oktober 2018 Aanpassingen: Documenten tabblad: De actie symbolen hebben een andere volgorde gekregen: Bekijk-Download-Bewerk-Archiveer-Verwijder. Ook is het Archief symbool is aangepast. De grootte van het "Alleen lezen" scherm past zich nu ook aan als de grootte van de browser wordt aangepast terwijl het bestand al geopend is. Bij het toe
Castor CDMS supports the storage of metadata with your fields, so you can enrich your data set with metadata like SNOMED codes, LOINC codes, or whichever type of metadata you want. To learn more about metadata, follow this link. Define Metadata Annotation Types In the Settings tab, click on the sub-tab ‘Annotations’ where you can manage all your
If respondents do not want to participate in your study anymore, they should inform a member of the study team. That member (or another study user with sufficient permissions) can archive the planned survey invitations for that study. By archiving the survey invitations, the surveys will not be sent. Read more about archiving survey invitations and
Please note - users can only be managed by system administrators. Users overview/table: The 'Users' tab shows all active users in the SMS environment. All user management actions can be completed in this tab. The user names and email addresses in this example have been made invisible. The GCP column on the left shows the status of the user’s GCP tra
Dinsdag 5 maart 2019 Aanpassingen: Rollen en rechten: Gebruikers met een User rol kunnen vanaf nu: geen bestanden uit het Documenten tabblad van een studie verwijderen; geen amendementen uit het Amendementen tabblad van een studie verwijderen. Filteren: Vanaf nu is het mogelijk om een filter op te slaan in het algemene Studies menu. Vanuit het Taken
In Castor SMS, each multiple choice field has an option group with different options. It is possible to add a new option or edit an existing option in an option group. Follow the steps below to add or edit an option in an option group: To edit an option group, first navigate to 'Settings' > 'Configurations' and click on the 'Option groups' tab. H
For English see below Dinsdag 19 mei 2020 Aanpassingen: Export Rapportage 'Inclusie aantallen' is toegevoegd, deze rapportage geeft inzage in de inclusie aantallen. In rapport rapportage 'Overzicht RvB' wordt weergegeven hoeveel dagen een studie op een bepaalde status heeft gestaan. Vanaf nu worden ook het aantal dagen berekend als de studie nog ste
You can enter data with different measurement units, and standardize all collected data with the same measurement unit with a calculation. For example, let's say that you are collecting the medication dose, which can be entered in mg, g, and kg. With a calculation you can automatically show all medication doses in grams: Use the following template a
It is possible to select one or multiple options in a checkbox field. In the export, every option becomes a variable, which looks like: variabelename#optionname If the option has been selected, then the value of this field will be equal to 1. If the option has not been selected, then the value of this field will be equal to 0. For example, a checkbo
Your Castor account details can be used to access both Castor EDC (Electronic Data Capture) and Castor SMS (Study Management System). If you have already created a Castor account, you can use these credentials to sign in to Castor SMS. If you have not yet registered for a Castor account, please register your account first. To register a Castor accou
Woensdag 22 augustus 2018 Aanpassingen: Restrictie voor nieuwe gebruikers van buiten het ziekenhuis: Iedereen met een Castor account kan inloggen in Castor SMS en een nieuwe studie aanmaken. Hier zijn nu restricties voor ingesteld. Vanaf nu kunnen alleen nieuwe gebruikers van het ziekenhuis direct studies aanmaken. De nieuwe gebruikers van buiten he
Castor SMS 2022.1 release certificate is available for download below. Release notes for 2022.1 can be found here. SMS_Release_certificate_signed.pdf
It is possible that you're trying to open a study and that you see the following error message: 'Could not open selected study. You don't have permission to enter this study. Please contact your study admin to request permission.' This means that you do not have sufficient user rights to enter the study while it is not live. Users will need at leas
Once the study is live, it is no longer possible to delete a participant/survey/repeating data. The only way to remove it from the current overview is to archive it. Archiving in Castor behaves almost in the same way as deleting - archived instances do not get exported with the data and do not influence the results of the study. The difference betw
If you want to enter data into surveys manually (e.g. if you have collected survey data on paper), then you can do the following: Create the survey forms in Castor. Create survey invitations in bulk or per record. You can choose to enter your own email address, as creating survey invitations requires an email address. For the 'Send on date', choose
Castor EDC/CDMS supports CDISC ODM-XML for the study structure and data export. The base version of standard is ODM-XML version 1.3.2. This feature is currently available upon customer request without any additional fee. To enable it please contact Castor support at support@castoredc.com and provide the study id where you would like to have this f
After you have created your automations, you can easily view and edit them. If you don't have an automation, try creating one! View automations To view the list of all of your current automations, navigate to the Settings tab and then to the Automations sub-tab. See the screenshot below. If you have no automations in your study, the chart will be em
Once a participant has been created, it's not possible to modify the participant id. It is possible to export the data that has been collected for this participant id, then create a new participant ID and import the collected data into the new participant id, following the steps below. Please note that it is only possible to import study and repeati
The action describes the result of the event triggering. Open the action dialog After you navigate to the Automation Engine and select an event, click on the "Action" button (1). Select an action A pop-up will show up in which you can select an action: Search for an action: As more actions are supported by our system, you will be able to search for
Dinsdag 8 januari 2019 Aanpassingen: Snelheidverbeteringen zijn doorgevoerd voor: het laden van het algemene Studies menu; het direct direct openen van een studie aan de hand van de studiespecifieke URL. Notificaties: Een aantal nieuwe variabelen zijn toegevoegd bij het instellen van de e-mail templates: WMO studie, Locatie, Verrichter/initiatior, F
The 'Upload file' field allows users and survey participants to upload files up to 5 MB in size. It is possible to upload larger files (up to 2GB per file) by purchasing the Large File Upload feature for your study. All file types are accepted, with the exception of executable files and SVG image files. Please note that at the moment, it is only
What is changing in version 2023.1 of Castor Connect? Participants must currently create and use a unique 4 digit PIN to access the Castor Connect app. As of version 2023.1 of Castor Connect, participants will be asked to create a 6 digit PIN and enable native security on their device to access the app. Native security will be the primary method for
Add documents to a study Go to the 'Studies' tab. Open the study. Go to the 'Documents' tab. Click on 'Upload document'. Fill in the form. Select one or multiple documents that you want to add to the study. Please note that only documents in the following formats can be uploaded: png, jpg, jpeg, gif, bmp, txt, ppt, pptx, xps, eml, msg, xls, xlsx, cs
When requesting a quote from a participating/supporting department, it is important to add the number of requested operations/procedures first. Adding a participating department Go to the 'Studies' tab. Open the study. Go to the 'Participating departments' tab. Click on 'Add participating department'. Complete the form. Details: Fill in the general
If you don't need to know the exact date of an event, or only want to use the month and year, it is possible to enter partial dates in the Date field. This includes both a missing day, and a missing day and month. This will be reflected in configured web surveys, visit forms and repeating data forms and their printables. Learn more about validating
For English see below Dinsdag 21 april 2020 Aanpassingen: Bij de goedkeuringsaanvragen is de status optie "On hold" toegevoegd, inclusief een veld om de reden voor on hold te noteren. De volgende notificatie gebeurtenissen die automatische e-mails en taken kunnen activeren zijn toegevoegd (standaard gedeactiveerd): Goedkeuringsaanvraag op on hold: D
Surveys can be printed or exported as pdf before data has been entered (so that the survey can be filled on paper), as well as after it's been completed (for filing). To print a survey, locate it in the Surveys tab (either within a record or from the general Surveys tab). Click on the cogwheel icon next to the survey and select the option "Print
De veranderingen binnen Castor SMS worden bijgehouden in de audit trail. De audit trail is op twee plekken beschikbaar: 1. Het Audit trail menu in het algemene overzicht In het algemene overzicht worden de aanpassingen weergegeven van wat er binnen Castor SMS plaatsvindt. Voorbeelden zijn veranderingen in een studie, aanpassingen in een gebruikerspo
For existing & new customers: Castor will continue to deliver its services without interruption. Our teams have always been equipped to work from home, and can do so effectively. Phone lines have been routed to 2 applicable team members per phone line. Our availability during business hours will not be affected nor will the availability of our p
In Castor SMS, each field you see is represented by a label. Labels always exist in both Dutch and English, even if the preferred language is Dutch. It is possible to change a label for a field. Update a label by following the steps below: To edit a label, first navigate to 'Settings' > 'Configurations' and click on the 'Labels' tab Here you see
This tutorial outlines how to set up the randomization for your study. In our blog we provide a description of randomization in clinical trials and the method used by Castor. Always consult a statistician before setting up your randomization, to ensure proper selection of the block sizes and strata. To define the randomization settings for the
Before a study can be locally approved, all added approval requests must be accepted. You can find an overview of the study approval requests in the study’s ‘Approval requests’ tab. The overview includes the request name and status.
For English see below Dinsdag 6 april 2021 Bug fixes: Sommige gebruikers met specifieke rollen hadden soms problemen met het openen van documenten of het openen van studies. Dit probleem is nu opgelost. In sommige gevallen was het niet mogelijk om een goedkeuringsaanvraag te ondertekenen, dit is hersteld. Tuesday April 6, 2021 Bug fixes: There were
Het is mogelijk om bij bepaalde gebeurtenissen automatische taken te laten genereren door Castor SMS. Ga naar het Instellingenmenu, subtabblad Notificaties. Het instellen van een automatische taak gaat in 2 stappen: Selecteer een gebeurtenis Configureren van de instellingen van de automatische taak Stap 1: Selecteer een gebeurtenis Een automatische
De gegevens in Castor SMS kunnen gemakkelijk naar een Excel bestand geëxporteerd worden. Ga via het algemene Studies menu naar de 'Export' knop en kies de gewenste export functie. Een van de voorgedefinieerde export rapporten Een zelf te maken export rapport middels "Uitgebreide export" Selecteer de te exporteren velden en klik op "Exporteren" om de
Repeating Data structure for Protocol Deviations Repeating Data structures have a 'one to many' relationship with a participant. Because of this, repeating data structures are useful for collecting information about deviations. It is recommended that the ‘Repeating Data button’ is utilized and dependencies are created where a deviation may occur.
Met een Castor account kun je zowel inloggen in Castor EDC (Electronic Data Capture) als in Castor SMS (Study Management System).Heb je al een Castor account? Je kunt dan direct inloggen.Heb je nog geen Castor account? Dan dien je jezelf eerst te registreren. Registreren Castor account Ga naar de login pagina van de Castor SMS omgeving van jouw inst
Dinsdag 3 april 2018 Aanpassingen: Aanpassingen in de audit trail: De audit trail wordt nu aan alle gebruikers getoond, niet meer alleen aan gebruikers met de Admin rol. Gebruikers zien alleen de audit trail die voor hen van toepassing is: aanpassingen in het eigen gebruikersprofiel en aanpassingen in de studies waar zij inzage rechten voor hebben.
Please note - approval stages of documents and amendments can only be managed by system administrators. Manage approval status of documents Go to 'Studies' tab. Open a study. Go to the 'Documents' tab. Open a document. Select the required status. Click 'Save' to save the changes. Manage approval status of amendments Go to 'Studies' tab. Open a study
Personal menu Your personal menu can be found on the top right corner of your window. Click on the person icon inside the circle to view the options: Language settings: Select your preferred language. Castor SMS is available in English and Dutch. Logout: Click here to log out of Castor SMS and end your session. By the left side, you can see a questi
Het is mogelijk om Castor EDC studies te linken aan Castor SMS studies. Hierbij worden gegevens vanuit Castor EDC getoond in Castor SMS. Het gaat hier om de instituut ID's, instituut namen en aantal records (inclusies). Castor SMS haalt alleen de gegevens op van de gelinkte Castor EDC studie waar de gebruiker in Castor EDC toegang tot heeft. Het gaa
Learn how to easily export data from a CSV file into SAS in Castor CDMS. If you would like to export data directly in the SAS format, please visit the article Export into SAS. First export your data with the export type 'CSV'. From here there are two ways to import your Castor data in the CSV files into SAS: Code Import data directly from your fold
A study team member with PII rights can withdraw a participant from the participant list. This article outlines the steps necessary to withdraw a participant securely and update the study records accordingly. 1. To mark a participant as withdrawn, start by navigating to the ‘Participants’ listing. 2. Locate the participant you wish to mark as
Vrijdag 22 februari 2019 Aanpassingen: Aanpassingen Studies menu: Favoriete studies - Middels de rechtermuisknop is het mogelijk om een studie als favoriet aan te merken. De favoriete studies worden getoond in het "Favoriete studies" tabblad. Laatst geopende studies - De 10 meest recent geopende studies worden vanaf nu getoond in het "Laatst geopend
Dinsdag 16 juli 2019 Aanpassingen: Elektronisch ondertekenen van goedkeuringsaanvragen: Goedkeuringsaanvragen die zijn goedgekeurd kunnen digitaal ondertekend worden door de gebruiker met de gerelateerde goedkeuringsaanvraag rol, of door een Admin.Aan de audit trail zijn twee nieuwe gebeurtenissen toegevoegd: "Handtekening toegevoegd" en "Handtekeni
Dinsdag 30 oktober 2018 Aanpassingen: Taken: Bij het toevoegen van een taak kan nu ook een automatische e-mail verstuurd worden. De e-mail wordt verstuurd naar de geselecteerde gebruiker(s) of de geselecteerde gebruikersrol: Unlocken van een gebruiker: Het account van een gebruiker die een aantal keer achter elkaar een foutief wachtwoord heeft ingev
Castor SMS 2022.3 release certificate is available for download below. SMS Release certificate 2022.3.pdf
Toevoegen van een of meerdere documenten Ga naar het Studies menu; Open een studie; Ga naar het Documenten tabblad; Klik op "Upload document" en selecteer één of meerdere documenten; Vul per document het formulier in en klik op "Volgende" indien er meerdere documenten zijn; Klik op "Klaar" zodra alle gegevens bij de documenten zijn toegevoegd. Het d
Improved Knowledge Base The Castor Knowledge base is your platform for browsing articles, release notes, connecting with the support team via chat and much more. The platform has gone through an update and we are excited to share the improvements! Sections Overview The knowledge base is divided into several sections: - EDC/CDMS - eConsent
With Castor EDC, you can securely store personal data by using the encryption module. To start encrypting fields, you first need to enable encryption for your study. Enable encryption for your study Open the Settings tab Navigate to the Study properties tab Check the box Field encryption Click the button Save changes Please note: Encryption is a pa
While your study is under development, i.e. before going live for the first time, you can set up, test, and modify the randomization settings. When going live for the first time, you will be offered to reset the randomization, thus effectively clearing up all test randomization data. Once the study has been live, even if later changed back to 'not
To edit a Visit or a Form, follow the steps: Go to Study Structure While on the Visit Tab, hover over the visit/form which you want to Edit From the kebab menu (the three dots) Click ‘Edit Visit/Form’. A pop-up will appear where you can alter the fields you used to create the Visit/Form (position, Form name, Form description): Now that you ha
Planned release date: 1 February 2022 ENGLISH: System defect fixes: In some cases, it wasn’t possible for Castor Admins to make changes to option groups. This has been fixed. We solved some defects with regards to the new privacy tab Some of the fields were automatically prefilled with ‘No’ There were two small spelling errors in this tab One of the
Before attempting to link two studies, make sure that you have the necessary user rights. Only users with “Manage settings” rights can create a linked study, review changes, review data impact and apply changes (otherwise all actionable buttons are disabled). Option Groups Option Groups that are not being actively used in your study forms may be dis
Wat is een goedkeuringsaanvraag? Een goedkeuringsaanvraag is een verzoek om een akkoord te geven. Denk hierbij aan een akkoord van een jurist, financial controller, privacy deskundige, deelnemende/ondersteunende afdeling of een medisch hulpmiddelen expert. Gebruikers met een normale gebruikersrol (leden van het studieteam) hebben alleen inzage recht
For English see below Dinsdag 8 september 2020 Aanpassingen: In het Gebruikersmenu zijn de filters aangepast: De filters hebben een nieuw uiterlijk gekregen en zijn te vinden middels de 'Filter' knop. De volgende filters zijn nieuw toegevoegd: Instituut Afdeling Functie Rol Bij monitorvisites kan meer informatie geregistreerd worden door twee nieuwe
Release date: 2 November 2021 ENGLISH: Updates: When receiving a notification about a newly added task that was assigned to you, you will now see who created that task. New features: In some situations, it can be desirable that a user does not have access to all the documents in a study. We have now made it possible to restrict document access for c
If you want to give a message when the date is more than X days before today, or in the future, you can use this formula. In this example 10 days or more are used as the limit. You can enter your variable name between these brackets {Variablename} var castorDate = moment('{Variablename}','DD-MM-YYYY'); var today = moment(); var tenDaysAgo = mome
Wegens de kerstperiode wordt de nieuwe release niet op maandag 25 december uitgerold, maar op donderdag 28 december 2017. Toevoegingen & aanpassingen Als een gebruiker aan een studie wordt toegevoegd (Studieteamtabblad) dan ontvangt deze gebruiker een notificatie per e-mail. De automatische e-mails naar het wetenschapsbureau werd altijd getrigge
This article explains the difference between the different study design types in the Study Settings tab. The choice of a study design type influences the availability of certain features and the pricing of the study. Prospective Prospective studies are specific types of research projects with a defined set of research outcomes, where the data is c
Castor EDC has been designed and developed to be in compliance with 21 CFR Part 11. Castor achieves compliance through a combination of risk assessment, SOP adherence, and by establishing a structured validated system. Please download the Assessment of Compliance here: 21 CFR Part 11.
After a survey has been created, you can use the survey button to allow users to quickly send the survey from your CRF. You can add a field in your study forms that will display a button which can quickly send a survey during data entry. The surveys are automatically linked to the parent visit, so you can easily keep track of when specific events ha
Dinsdag 26 juni 2018 Aanpassingen: Het Taken menu en Taken tabblad binnen een studie: Alle gebruikers zijn nu bevoegd om taken die zij zelf hebben aangemaakt te bewerken en verwijderen. Dit was voorheen alleen voorbehouden aan gebruikers met een Admin rol. De kolommen en filters "Toegewezen aan gebruiker" en "Toegewezen aan rol" zijn toegevoegd. Er
Each study has a version number which is updated depending on the actions performed in the study. The version number is updated based on the following actions: adding a field +0.1 adding a visit or form +0.1 adding a repeating data doesn't have any effect, only adding a repeating data form +0.1 adding a survey +0.1 adding a survey form +0.1 dele
To create a validation warning or a dependency when there is no data entered in a field, you can use a calculation field to check if any data is entered. See ‘ Forcing Castor to calculate with empty fields ’ for more information on empty fields. The below calculation will check for empty or ‘NA’ values within a field. '##allowempty##'; if("{Var
Using Castor SMS for the first time Each hospital/institute has its own custom url, which links to the hospital specific Castor SMS environment. You can access a demo version of Castor SMS using demo.castorsms.com - you can login using your usual account credentials. Create a profile After logging in, you will be prompted to create your user profile
The audit trail is a log of study related events. To view additional details for each event, click on the row:
From time to time we may update the app to improve the experience through new features and improvements. Many devices will automatically download and install any updates, but some don’t so we’ve provided instructions to allow you to check: Castor Connect is compatible with the following software versions: Android 8 (and all later updated versions) i
We are excited to announce the launch of Castor eConsent! Castor now supports recruitment of patients through a customized portal that automates enrollment workflows. This includes a study-unique enrollment page and a flow to obtain electronic informed consent from the participants. How will it work? In a nutshell: participants can register their i
For English see below Dinsdag 14 januari 2020 Aanpassingen: Dashboard menu: Een grafiek die het aantal ingediende amendementen weergeeft is toegevoegd Het is mogelijk om individuele grafieken te downloaden (exporteren) in een png bestand Audit trail log "Dashboard bekeken" is toegevoegd Documenten tabblad: De maximale grootte van bestanden is verhoo
Woensdag 30 oktober 2019 Aanpassingen: Amendementen: Kolom 'Ingediend op' is toegevoegd aan het Amendementen tabblad. Audit trail: Het openen van het Gebruikers menu wordt vanaf nu weergegeven in de audit trail. Export: Type CRF systeem is toegevoegd aan de export rapporten "Overzicht voor Raad van Bestuur" en "Overzicht bureau wetenschap". Institut
In Castor, a calculation used to perform mathematical operations applies rounding to two decimals by default. For example, we have two variables and we know that the result of adding them up should be 1392.43460062. We create our calculation in Castor: var measure1 = {my_variable_1}; var measure2 = {my_variable_2}; measure1 + measure2; The result o
Admin gebruikers van het instituut kunnen templates voor brieven toevoegen met daarin Castor SMS studievariabelen. Bij het downloaden van een brief template vanuit een studie worden de waardes van de studievariabelen automatisch geïmporteerd. Stappen: Open de studie en ga naar het "Templates" tabblad; Klik op het download-icoon of gebruik de rechter
Maandag 22 januari 2018 Aanpassingen In het Gebruikersmenu (alleen inzichtelijk voor gebruikers met een Admin rol) zijn 2 nieuwe kolommen toegevoegd: CV en Rol. In het Studie inhoudtabblad bij het veld "Welk type aandoening wordt bestudeerd?" is de optie "Infecties en parasieten" toegevoegd. Tevens zijn alle labels van de opties gelijk gemaakt met d
Toevoegingen & aanpassingen: De vraag in het METC tabblad over wie er verantwoordelijk is voor de monitoring gaf de antwoordopties DSMB en Anders (let op: dit was niet van toepassing voor alle Castor SMS omgevingen). We hebben hier twee aparte vragen van gemaakt om een duidelijker onderscheid te maken tussen monitoring en een DSMB. De taalinstel
Dinsdag 24 juli 2018 Aanpassingen: Controle en indienen tabblad: Vanaf nu kunnen alleen Admins een studie indienen bij/doorzetten naar de Raad van Bestuur. Voorheen konden ook leden van het studieteam dit doen. Het tabblad is volledig naar boven verplaatst waardoor het voor gebruikers duidelijker wordt dat dit tabblad gebruikt kan worden voor het in
Maandag 28 mei 2018 Aanpassingen: Documenten tabblad: De bestandstypen die toegevoegd kunnen worden is beperkt. Bij het toevoegen van een bestandstype dat niet wordt ondersteund wordt er een foutmelding getoond Bij het toevoegen van een te groot bestand wordt de volgende foutmelding gegenereerd: Bij het aanpassen van het toegevoegde bestand wordt oo
For English see below Dinsdag 10 december 2019 Aanpassingen: Een Dashboard menu is toegevoegd: Er zijn twee weergaven: goedkeuringsaanvragen en amendementen. De data kan middels grafieken of een lijst getoond worden. De tijdsperiode kan zelf gedefinieerd worden. Rollen en rechten: Admins hebben standaard toegang tot alle weergaven van het dashboard.
Add documents to a study Go to the 'Studies' tab. Open the study. Go to the 'TMF' tab. Click on '+ Documents'. Select one or multiple documents that you want to add to the study. Please note that only documents in the following formats can be uploaded: png, jpg, jpeg, gif, bmp, txt, ppt, pptx, xps, eml, msg, xls, xlsx, csv, pdf, doc, docx, docm, odt
It is possible to link Castor EDC studies to Castor SMS studies. Via this integration, Castor SMS receives data from Castor EDC. This concerns the institute names, the institute ID's and the number of records (= inclusions). Castor SMS only receives the data from Castor EDC that the logged-in user has rights for. It concerns the number of 'active' r
For English see below Dinsdag 10 maart 2020 Aanpassingen: Notificaties: Gebeurtenis "Studiedocument toegevoegd na RvB goedkeuring" is toegevoegd. Documenten tabblad: Het aantal documenten (rijen) per pagina kan ingesteld worden. Controle en Indienen tabblad: Alleen de actieve documenten worden meegenomen bij de controle of alle verplichte type docum
Dinsdag 1 oktober 2019 Aanpassingen: Integratie Castor EDC: Het is vanaf nu mogelijk om een Castor EDC studie aan een Castor SMS studie te linken. Zodra een studie gelinkt is worden de instituten en het aantal records (proefpersonen) vanuit Castor EDC in Castor SMS weergegeven. Door middel van de Synchroniseer knop kan telkens de data opnieuw opgeha
Release date: 7 June 2022 ENGLISH: New features and / or enhancements Allow Castor admins to set up automatic study numbering from Settings This feature is not accessible to users yet. Change the formatting of the EudraCT number field in METC tab The format of the EudraCT number has changed, it is now possible to use both the old and the new format
*This app cannot be used on its own by the general public.* We have built an app as part of a larger research infrastructure provided by Castor, that supports the recruitment and enrollment of healthy volunteers to support COVID-19 studies. This app asks healthy volunteers to report their symptoms on a day to day basis, so that the population can be
Nieuwe feature voor rollen en rechten: Deze release staat in het teken van de oplevering van de vernieuwde rollen-en-rechtenfunctionaliteit. Via het Instellingenmenu (alleen zichtbaar voor gebruikers met een Admin rol) kunnen rollen aangemaakt worden. In de volgende artikelen wordt stap voor stap uitgelegd hoe deze nieuwe feature werkt: Rollen en r
Dinsdag 20 maart 2018 Nieuwe feature: Het is vanaf nu mogelijk om als Admin gebruiker zelf de automatische e-mail notificaties in te stellen. Admin gebruikers kunnen bij bepaalde gebeurtenissen de ontvangers en de inhoud van de e-mail instellen. Op deze manier kan voor iedere Castor SMS omgeving andere e-mail temples gebruikt worden. In het volgende
Castor eConsent platform supports two consent methods: Electronic (created with the eConsent ICF Builder) or Paper (used to upload a form signed on paper). Consenting can be done electronically with a subject account or without a subject account (in-person signing). In cases where a paper consent method is used, signed consent forms can be uploaded
If a subject is being seen at site A and would like to continue care at site B. You can create a site called “A-B” that would allow both sites access to the participants for the subject. Navigate to the settings Click on study Click Manage sites Add site “A-B” After which you can assign the subject to the new “A-B” site. Please note users from e
Changes within Castor SMS are tracked in the audit trail. The audit trail is available in two locations: The Audit trail menu in the general overview:In the general audit trail users can see all changes that happened within Castor SMS. Examples are changes in a study, changes of a user profile or adding of a new user role. Users will only see the ch
Release date: 5 Apr 2022 ENGLISH: System defect fixes: After adding the option to create automatic approval requests, the former custom generated approval requests had to be removed. This has now been corrected. When creating a task, you can decide whether an email has to be sent after the completion of a task. This was only working for tasks that w
The 'Documents' overview The Documents overview provides a list of all documents you have access to. This overview is across all your studies. Display Searching: You can search on file and on content. Hit the 'Enter' key or the 'Search' button to preform the search. Filtering: Use the 'Filter' button to open the filter bar and hit 'Apply' to activat
Woensdag 11 juli 2018 Aanpassingen: Nieuwe gebruikers die zichzelf registreren dienen het nieuw aangemaakte Castor account te activeren middels een actievatelink die per e-mail wordt verstuurd. Gebruikers met een onvoltooide registratie kunnen niet inloggen. Zodra gebruiker met een onvoltooide registratie probeert in te loggen wordt vanaf nu de regi
You can use the Castor API R package to access study data in Castor via R. Please note that the 'castoRedc' project is released with a Contributor Code of Conduct. By contributing to this project, you agree to abide by its terms. For a simple data export and/or study and report data merge, see: How can I export and merge data in R? To get started wi
The full overview of all data and their methods/functions that you can use to retrieve them can be viewed on the Castor API R Package project page. Check our Using the Castor API R package for data analysis tutorial to get started with the R package. If you need other data, you can also check out the API documentation and the article Which data fro
In this page you can find various resources that are useful when working with Castor EDC/CDMS. Form Exchange The Form Exchange is a platform where you can up- and download forms, repeating data and surveys to be shared with the community of Castor users. You can also find (and test) useful calculations that cover specific demands. In this article yo
You can hide parts of the eCRF for certain data-entry users. This means that they will not see a specific part of the form while doing data entry. All users with 'Manage forms' rights will still have access to the full form in the ‘Study Structure’ Editor You will first need to define user roles as per this article. To hide parts of the eCR
For English see below Dinsdag 25 februari 2020 Aanpassingen: GCP/BROK: Veld "Certificaat geldig tot" is toegevoegd aan het gebruikersprofiel. Bij het invullen van de datum behalen certificaat wordt automatisch 3 jaar bij de datum behalen certificaat opgeteld en ingevuld in dit nieuwe veld. De GCP/BROK herinneringen (e-mails en taken) worden nu niet
Yes - Castor gives the option to choose the time from a dropdown menu showed in quarter intervals. It is possible to use an exact timestamp by manually entering the time in the field. The time must be entered in the format HH:MM e.g 09:47.
Please note - templates can only be managed by system administrators. Templates in Castor SMS they can be made available for other users of the system using the publish function. Castor SMS variables can be added into the templates to automatically import data when downloading the template from within a study. Publish a template Go to the 'Settings'
The respondents can still fill in the surveys even when the study is 'not live', if they have access to an active link. The data will be automatically saved, just like when the study is live. We recommend to lock the surveys when they are finished to prevent further modifications. This can also be done automatically, by selecting the option 'lock s
Lijkt er een probleem te zijn met Castor SMS? We laten de status van alle Castor applicaties zien op de Castor Status page: https://castorstatus.com/
Wat is een goedkeuringsaanvraag? Een goedkeuringsaanvraag is een verzoek om een akkoord te geven. Denk hierbij aan een akkoord van een jurist, financial controller, privacy deskundige of een medisch hulpmiddelen expert. Het "Goedkeuringsaanvragen" tabblad biedt een overzicht van goedkeuringsaanvragen. Het is niet* mogelijk om zelf een goedkeuringsaa
Het tabblad "Monitors" biedt een overzicht van de monitors en de monitorvisites. Middels de start- en stopdatum van de monitor wordt inzichtelijk wanneer de monitor toegang dient te krijgen in het EPD.Dit tabblad wordt alleen getoond bij WMO-plichtige studies. Het toevoegen van een monitor: Klik op de knop "Voeg een nieuwe monitor toe". Vul de gegev
It is possible to check if a text field contains only capital letters. This is done using regular expression (/^[A-Z]+$/). The following template will allow you to validate the capital letters: if ((/^[A-Z]+$/).test('{text_field}')) { "OK" } else { "Please use capital letters" } Check this template in the calculation helper.
It is possible to assign a status to each participant if your study administrator has created relevant statuses in the Settings tab. Adding a status to a participant is only possible for study team members with Edit rights. Your browser does not support HTML5 video. To add a status for an individual participant, open the participant and select the r
This article lists errors that you might receive when using the API, as well as potential causes and solutions. These will also be listed in the endpoints in the API documentation. We recommend that you try the endpoints from our documentation page directly, so that you can check whether there is something going wrong in Castor EDC or in your code
The Castor CDMS API Documentation page gathers the methods and requirements of the fields in Castor to be used with an API. EU API endpoints UK API endpoints US API endpoints AU API endpoints The Changelog of the Castor CDMS API can be reviewed here. There are a handful of parameters that are used to locate the data in the database and retrieve it
The following PDF files include instructions for the usage of Castor EDC according to the three default user roles. You can download or print these files for your own documentation: Study admin instructions This PDF file contains manual instructions for study admins. It contains instructions for creating and testing a study, and information about ad
The following PDF files include instructions for the usage of Castor EDC according to the three default user roles. You can download or print these files for your own documentation: Study admin instructions This PDF file contains manual instructions for study admins. It contains instructions for creating and testing a study, and information about ad
The following PDF files include instructions for the usage of Castor CDMS according to the three default user roles. You can download or print these files for your own documentation: Study admin instructions This PDF file contains manual instructions for study admins. It contains instructions for creating and testing a study, and information about a
Het bijhouden van inclusies, voorgangs- en eindrapportages worden toegevoegd in het tabblad "Studie voortgang". Dit tabblad wordt pas zichtbaar zodra de studie het indieningsproces heeft doorlopen en goedkeuring heeft gekregen. Toevoegen inclusie aantal: Klik op de knop "Toevoegen inclusie aantal": Vul de velden in en klik op "Opslaan": Instellingen
Sending individual surveys via Castor Connect app Having set up your mobile-enabled survey package, you can now send them to participants either through individual survey package invitations, or in bulk via the participants overview. Selecting a mobile-enabled survey package brings some minor amendments to the fields available: After enabling Castor
Castor CDMS 2022.5 Release Certificate is available below. Release Certificate 2022.5
For English see below Woensdag 3 juni 2020 Aanpassingen: Bij het exporteren van de actieve documenten in een e-mail of brief wordt bij de versievoering van het document nu zowel versienummer als versiedatum weergegeven. Wednesday June 3, 2020 Changes: Besides the version number, also the version date is exported in the active documents variables (em
The following PDF files include instructions for the usage of Castor EDC according to the three default user roles. You can download or print these files for your own documentation: Study admin instructions This PDF file contains manual instructions for study admins. It contains instructions for creating and testing a study, and information about ad
If you need to retrieve and display today's date, there are two ways of doing this: 1) Using JavaScript in-built function to get the current date: var d = new Date(); var datestring = d.getDate() + "-" + (d.getMonth()+1) + "-" + d.getFullYear(); datestring; Check the calculation in the calculation field helper here. 2) Using the Moment.js librar
The following PDF files include instructions for the usage of Castor EDC according to the three default user roles. You can download or print these files for your own documentation: Study admin instructions This PDF file contains manual instructions for study admins. It contains instructions for creating and testing a study, and information about ad
Release date: 3 May 2022 ENGLISH: New features and / or enhancements Hide 'link to EDC' buttons Some recent changes with regards to logging into Castor EDC have caused the 'link to EDC' functionality to break. While we investigate the issue, we have removed the button from the Study Progress tab, to avoid any confusion. Allow to hide the invoice a
It is possible to produce annotated CRFs within Castor by printing an empty CRF, see detailed instructions how to achieve this in this article Print the study forms Alternatively, in Castor it is possible to export the study structure, including metadata, if you have metadata in your study. It is also possible to export a data dictionary for your
Woensdag 7 augustus 2019 Aanpassingen: Audit trail: De volgende gebeurtenissen zijn toegevoegd aan de audit trail: Export uitgedraaid Document bekeken De volgende nieuwe velden zijn toegevoegd: 'Instituut type' in het tabblad 'Contactgegevens' van een instituut; 'Studie fase hulpmiddel' in het tabblad 'METC' van een studie. Dit veld wordt alleen get
To inactivate the previous versions of an ICF, follow the steps below: 1. Navigate to the ‘Consent forms’ tab. 2. In the ‘Options’ column, click on the three dots menu for the form you want to deactivate and choose the ‘Archive’ option: 3. Click on ‘Archive’ button to confirm the action: 4. After the form is archived, the ‘Document status’ column
In eConsent platform, it is possible to use a paper ICF form only or a hybrid model with both paper and electronic consent forms. To be able to use both consent methods, follow the steps below: 1. In the 'Study settings' tab, navigate to the 'Configurations' sub-tab and make sure the option 'Allow for paper consenting (this will be used to upload pa
The table below shows an overview of the fields for which data can be sent (POST) and retrieved (GET) with API endpoints. See also the introduction to the API and the API documentation. Action Field Possible? POST (send) data Encrypted fields Yes Grid fields No Upload file fields Yes User missing values Yes GET (retrieve) data Encrypted fields No,
If you want to add hours and minutes to a date & time field, you can use this template. For this calculation, you will need a date & time field and a time field which are called 'datetime' and 'add_time' in this calculation. //Set datetime into right format to add hours and minutes var splitted_datetime = '{datetime}'.split(';'); var split
When two studies are linked via the Formsync feature, a new event is created and added to the audit trails of the production study and the test study. ‘Link Study created’ event contains: Linked By: <username> <email> Linked On: <date> <time> ‘Study unlinked’ event contains: Unlinked By: <username> <email> Unlin
Let op: deze functionaliteit is alleen beschikbaar voor gebruikers met een Admin rol. Door het toevoegen van (brieven) templates met Castor SMS studievariabelen wordt het mogelijk voor andere gebruikers om deze templates vanuit een studie te downloaden. Bij het downloaden van een template vanuit een studie worden de waardes/data van de variabelen au
When choosing an electronic consent method, participants can consent online with an account or in-person without creating an account. It is not necessary to schedule a call to obtain consent. For detailed instructions on how to sign a consent form electronically without a televisit, please review the articles below: Electronic signing with an ac
Custom columns can be created to display specific variable values in the Repeating Data overview. Setting up custom columns This functionality can be enabled and set up through the following steps: 1. Go to the Settings tab and scroll down to the section "Other." 2. Click on "Manage custom columns" button in the ‘Repeating data overview custo
To consent remotely via a video call, follow the steps below: 1. Make sure that the ‘Video calling for signing’ option is enabled in the 'Study settings' tab, ‘Configurations’ sub-tab. This will activate the possibility to perform a video call. 2. Once the configuration is enabled, when opening an individual subject, a ‘Consent call’ card will a
Dinsdag 12 november 2019 Aanpassingen: Apparatuur: In het Instituten menu kan per instituut de apparatuur (MRI, DXA) geregistreerd worden. Notificaties: Notificatie gebeurtenis 'Herinnering toevoegen startdatum nWMO' is toegevoegd. Bug fixes: Gebruikers menu: Bij het toevoegen van een gebruiker die al was toegevoegd bleef SMS laden in plaats van dat
Castor SMS ondersteunt het wetenschapsbureau en de onderzoeker bij het indienings- en goedkeuringsproces van studies. Toevoegen van een nieuwe studie: Ga naar het Studies menu (hier worden de studies getoond waar jij inzage rechten voor hebt); Klik op Nieuwe studie; Vul de verplichte velden in en klik op Doorgaan. De studie is vanaf nu toegevoegd aa
Release date: 21 July 2021 Added features and / or functionalities Monitoring / Queries Besides migrating all previous functionalities, information and features of the Monitoring module in a new interface that is more intuitive and easy to use, we’ve introduced a few new features to the Queries overview. A new ‘Action’ menu button for global actions
Planned release date: 18 August 2022 Repeatable Surveys Survey packages can now be configured as ‘Repeatable’ within the survey package configuration UI. Applying this to a survey package will make, after being completed once, available for re-completion in a new ‘as needed’ activities list in the Castor Connect app. Re-submitting a survey packa
Main features & improvements Encryption Encryption will be available as a premium feature and can be enabled in the study settings. More information around the entire feature can be found in the relevant manual section. Surveys It is now possible to copy survey packages. When copying survey packages the following is copied: Intro text, outro tex
Admin users can tell for each field whether it should be visible and if the study can be saved without having data entered in the field. This article will explain how to manage these field configurations. Hiding a field In Castor SMS, a lot of fields exist. Not all fields might be applicable for your site, so these could be hidden to avoid having l
Study team members eConsent forms can be build in any language. Castor eConsent supports UTF-8 format and double byte characters. The eConsent platform is only available in English for study team members. Participants For participants, the interface and navigation buttons, as well as emails are available in the following languages: German, English,
The following PDF files include instructions for of Castor eConsent for study admins and team members and study participants. You can download or print these files for your own documentation: eConsent Study Admin User Guide 2022.5 eConsent Study Participant User Guide 2022.5
For existing subject, to add a new form, in the 'Profile' sub-tab, press the three dot menu and choose the option to 'Add new'. In the pop-up window, select applicable forms and click on the 'Add' button: Alternatively, after opening a subject, navigate to the 'Consent Forms' sub-tab and click on the 'Add new form' to add another consent form:
It is only possible to add participating centers to a study when ‘Multicenter, initiating center’ is selected in the ‘Multicenter study’ dropdown menu found in the study’s ‘Main’ tab. Add a new center / site to a study Go to the 'Studies' tab. Open the study. Navigate to the 'Participating centers' tab. Click on 'Add participating center'. Fill in t
This is a guide that helps with creating an automation (provided you have enabled Automations in the Study Settings) with the "Add Query" action. Please note that all of the below examples use the example forms Castor can provide you for a newly created study. If you need to add multiple queries to the same field, it can be done manually, please vis
To add hours or minutes to the time entered into a time field, you can use the following calculation template. For example, use this template to add 15 minutes: var addHours = moment('{your_time_variable}', 'hh:mm'); new_time = addHours.add(15, 'minutes').format('HH:mm'); new_time; Use this template to add 60 minutes: var addHours = moment('{y
Metadata are data that provide information about other data, generally a dataset. These data, in combination with documentation, help you, your colleagues, and computers to comprehend the meaning behind the data in the datasets. Metadata also enables interoperability (i.e. the ability to exchange data and interpret that data) since they provide a c
Castor Connect 2022.x.x 21 CFR Part 11 Statement of Compliance is available for download below. Castor Connect 2022.x 21 CFR Part 11 Assessment of Compliance v2.0.pdf
Castor's Notification settings allow for the creation of email notifications for specific repeating data types. Often users want to create a notification for serious adverse events or those Adverse Event repeating data structure (AE) where it was indicated that an event may have been related to study participation. The standard notification system o
Currently, it is not possible to import data into surveys. It is possible to import data into study forms and repeating data. If you want to enter data into surveys manually (e.g. if you have collected survey data on paper), follow these steps.
Castor Connect 2021.x.x 21 CFR Part 11 Statement of Compliance is available for download below. CastorConnect_2021.x_21_CFR_Part_11_Assessment_of_Compliance.pdf
Castor EDC/CDMS is ISO27001, ISO 27002 and NEN7510 certified and complies with all applicable laws and regulations: Good Clinical Practice (GCP), 21 CFR Part 11, EU Annex 11, and the European Data and privacy laws, including the recently implemented General Data Protection Regulation (GDPR).
For English see below Dinsdag 24 maart 2019 Aanpassingen: Notificaties: Vanaf nu is het mogelijk om in te stellen dat bij het indienen van een amendement ook de bijbehorende deelnemende afdeling op de hoogte wordt gebracht. Twee nieuwe filters zijn aan het Studies menu toegevoegd: EudraCT nummer Hoofdonderzoeker Deelnemende centra tab: Een nieuw vel
Let op: dit onderdeel van de handleiding is alleen van toepassing voor gebruikers met de 'admin' rol. Toevoegen en beheren van instituten/sites: In het Instituten menu worden de instituten/sites beheert. Deze instituten kunnen vervolgens gekozen worden in het profiel van een gebruiker en toegevoegd worden aan een studie in het Deelnemende centra tab
At the moment, it is not possible to create automations based on checkbox fields because automations with the same conditions cancel each other out. We suggest to use radio buttons instead. For better context, suppose you have a Checkbox Field (Intravesical Therapy) with 3 options to choose from. You would like to hide certain forms, based on the C
Use the templates below to calculate the difference between two date time fields. Replace datetime1 and datetime2 with your own variable names. If you want to round your numbers, replace m3 with: m3.toFixed(X); with X being the number of decimals. See also: Rounding numbers. In minutes var m1 = moment('{datetime1}', 'DD-MM-YYYY HH:mm'); var m2 = mom
After your study goes live, you cannot permanently delete data from the system. Participants, repeating data instances, and survey package invitation instances may be archived so that they do not appear in the overview. However, data remains available to be retrieved at all times in line with GCP guidelines. Soft deletion of data from an eCRF is
While the average is the result of performing some mathematical operations, the median is employed more as descriptive of the data set and usually involves no mathematics. The median is thus defined as the the middle value in a list of numbers, that can be sorted in ascending or descending order, leaving half of the values above and the other half
Castor CDMS supports usage on mobile phones and tablet devices. While this compatibility is something that we are working on improving, we would like to provide you with some helpful tips if the data entry users are navigating the study forms from a mobile device like a smartphone or tablet: Use a Pen tablet to improve interactions that require doub
If you are storing date and time in separate variables, use the template below to calculate the difference between a date and a time field and display the difference in hours: var d1 = moment('{date1}' + ' ' + '{time1}').format("DD-MM-YYYY HH:mm"); var d2 = moment('{date2}' + ' ' + '{time2}').format("DD-MM-YYYY HH:mm"); var date_1 = moment(d1); var
Release date: 1 Jul 2020 Main features & improvements Signature In the study settings it’s now possible to set up a signature statement. This statement is presented to the user when applying a signature. By signing the phase or step, the user declares what is written in the signature. After the study has gone live, it is no longer possible to ed
In het Gebruikers menu kunnen nieuwe gebruikers worden toegevoegd. Tevens biedt dit menu een overzicht van alle bestaande gebruikers in Castor SMS. Alleen Admins kunnen het Gebruikers menu zien. Overzicht gebruikers De gebruikersnamen en emailadressen zijn in dit voorbeeld onzichtbaar gemaakt. De gekleurde GCP/BROK iconen betekenen het volgende: Roo
Major release 2021.5.0.0 Release date 11th October 2021 Added features and / or functionalities Record Status mechanism Tracking records throughout the study lifecycle is critical. For most users, whether processing individual records, or summarized views of study progress, rely on this information for critical user-flows. We’re introducing a first
How do I get started? Complete survey using browser Your survey invitation email will contain a link. After clicking this link, it may open in a browser for you to complete the survey. Completing the survey questions The survey may contain multiple choice options or fields in which you need to type in your responses. In some cases, you might need t
To define data as missing, use the cogwheel to select the option 'user missing' and from the provided list, indicate the reason why the data is missing. Here are the default values / reasons you can choose from: Measurement failed (-95) Not applicable (-96) Not asked (-97) Asked but unknown (-98) Not done (-99) The accompanying numbers (shown in br
Dinsdag 18 juni 2019 Aanpassingen: Site management: Het is vanaf nu mogelijk om de deelnemende centra die aan een studie toegevoegd kunnen worden te beheren vanuit het Instituten menu. Het is vanuit het Instituten menu inzichtelijk welke studies er binnen welk instituut/deelnemend centrum lopen. Doordat de opties vanuit het Deelnemende centra tabbla
It is possible to add a link to forms using the following markdown: [Link title](www.example.com) Adding a link to the help/info text In the below example, a link is added to the help text for a field: The link will display in the participant after clicking on the i icon next to the field, as shown below: It is also possible to add a link to
It is possible to copy the field dependencies when copying a step. In order to do so you will need to choose to have the dependencies in the copied step reference to the original fields or the new copied fields. If the dependencies cannot be viewed in the copied step, the 'Copy dependencies?' option may have been set to 'No'. We recommend copying t
In Castor CDMS you have the option to verify collected data in your study. The most common example is source data verification (SDV), but you can also define your own verification type depending on the quality control that you want to use for your study data. To use this feature you have to first ensure that the correct study settings are applied a
Castor EDC/CDMS is a web application which can be accessed from anywhere using your Castor login credentials. For the best experience, we recommend using the latest version of Google Chrome, Mozilla Firefox, Safari, or Microsoft Edge (any operating system). It is recommended to use an up to date browser, for compatibility and security updates. Inter
Dinsdag 5 februari 2019, versie 2019.3 Aanpassingen: Templates voor brieven: Vanaf nu kunnen algemene templates voor brieven met Castor variabelen toegevoegd worden aan het systeem. Bij het downloaden van het template vanuit een studie worden de waardes van de variabelen automatisch geïmporteerd. Lees hier hoe een brief template toegevoegd wordt aan
Study data can easily be exported from any Castor study. You can choose between CSV, Excel, SPSS and SAS (SAS XPT or SAS 7BDAT) or CDISC-ODM formats and the data export will include a code book, or list of study variables and option group labels/values. Exported data in Castor can easily be imported into SAS, Stata, or R.
To calculate the total duration of the several time variables and output the duration in hours and minutes, use the following calculation template: var time1 = moment.duration('{time_var1}').asMinutes(); var time2 = moment.duration('{time_var2}').asMinutes(); var time3 = moment.duration('{time_var3}').asMinutes(); var total_min = time1 + time2 + t
You can add values from different fields together using a calculation field. For example, you can use this template to calculate a risk score based on multiple risk factors. In this example we use the MLHF (Minnesota Living with Heart Failure) questionnaire which is answered on a scale from 0 to 5 (very little - very much). The score of this que
At the moment it is not possible to export email addresses of the participants. To view an email address make sure you have View Email rights. Click on the three dots next to a participant and choose the option to Update email address: After entering your password, you will be able to view an email address linked to a particpant.
Yes, calculations can be used in your repeating data forms. This is done in a similar way to the calculations used in study forms. If you don't want the study team members to see the output of the calculation field, you can set the calculations to be hidden. The output of the hidden calculations will be included in the export of your repeating da
If you are using a randomization algorithm outside of Castor, you can import the randomization data into Castor as well. Follow the steps outlined below: Create a new field or fields which will contain the randomization allocation or other randomization data in your study forms - this can be for example a numerical field (for the randomization numb
You can check the status of the Castor systems by navigating to https://castorstatus.com /. Once you open the page you will be able to see if the systems are operating normally or there are, or were, any incidents. By clicking on ''SUBSCRIBE TO UPDATES'' you can also get notified whenever an incident is created , updated or resolved . Upon cli
Donderdag 20 september 2018 Aanpassingen: Documenten tabblad: Het "Alleen lezen" scherm van bestanden wordt nu niet meer in één standaard formaat geopend maar houdt rekening schermgrootte (browser). De bestandsnaam wordt nu in de header van het "Alleen lezen" scherm weergegeven. Het "Alleen lezen" scherm heeft een knop gekregen waardoor het scherm o
The number & date field allows a user to store a number value alongside a date. This field gets saved as a semi-colon separated string, e.g. "4;14-09-2020". To be able to perform calculations with these values, you have to split the string in separate values. For example, to access the number value in the number & date field, you can use: va
De aanpassingen die na de goedkeuring worden doorgevoerd kunnen in de het 'Amendementen' tabblad bijgehouden worden. Het toevoegen van een amendement: Ga naar het Studies menu; Open de studie; Ga naar het Amendementen tabblad; Klik op de knop Voeg amendement toe; Vul het formulier in; Merk aan of het amendement ingediend moet worden voor goedkeuring
For English see below Donderdag 22 april 2021 Bug fixes: Document type ID 80 had een verkeerd label, deze is aangepast. Technisch onderhoud: Er is wat technisch onderhoud verricht aan de Monitor, Amendementen & TMF tabbladen Thursday April 22nd, 2021 Bugfixes: Document type ID 80 had a wrong label, this has been corrected. Technical maintenance:
Yes, you can! You can import a csv file with email addresses. You need to prepare the file accordingly, with your participant IDs and email addresses in separate columns. Please read this article for more information: Bulk import of email addresses.
Yes, you can import repeating data into Castor. Please see our article about Importing Spreadsheet Data for more information.
You can import existing research data in Castor using the CSV file format. You first have to create your eCRF to contain the fields with the same variable names as in your data sheet. Please note that it is not possible to import queries, data validations, signatures, data verifications and comments. For a more in depth view on how spreadsheet data
Adhering to Good Clinical Practice (GCP) ensures data integrity and transparency during clinical trials. In CDMS, users must provide a reason when changing previously entered data to comply with GCP standards. This helps track changes and maintain an audit trail. Enabling GCP Features To enable this feature: Navigate to Settings, then Study under th
To cancel a survey invitation that is scheduled in the future, just archive it by pressing on the cogwheel. This will archive the survey invitation and stop any future scheduled sending.
For English see below Donderdag 5 november 2020 Aanpassingen: Een deel van de eTMF / eISF functionaliteiten zijn nu voor alle SMS klanten ter beschikking gekomen. Documenten menu: Dit menu laat alle documenten waar jij rechten toe hebt. Middels het zoekveld kun je op inhoud zoeken. TMF tabblad binnen een studie: Laat de studiedocumenten automatisch
Castor EDC/CDMS 2022.4 Release Certificate is available for download below. 2022.4 Release_Certificate.docx.pdf
Castor supports multiple center studies in which several sites can contribute to a study. For guidance on adding sites to a study, see the manual article: Settings.
Release date: 7/8 June 2022 Castor CDMS 2022.2.0.0 Release notes New features and enhancements Presenting a new overview of Pending SDV! We're rolling out a new overview for the global Verifications page. Users will now be able to access a table with all completed fields that are pending SDV (Source Data Verification). This will help them keep tra
Currently all the surveys have a standard font size. Increasing survey fields text size for certain types of fields can be done in certain situations upon a request at an additional cost. Please contact support@castoredc.com for more information by providing the study and survey name.
Castor CDMS 2023.2 Release Certificate is available below. Castor CDMS 2023.2 Release Certificate
Castor CDMS 2023.1 Release Certificate is available below. 2023.1_Release_Certificate.docx.pdf
Castor CDMS 2023.3 Release Certificate is available below. Castor CDMS 2023.3 Release Certificate
Major Release 2022.3.0.0 -Release date 18 August 2022 Overview/Important Alerts With this CDMS release, we are changing a few key terms throughout the user interface in order to better align with those more commonly used in our industry. By using terms more familiar to our users in Castor’s CDMS, we aim to reduce the learning curve and improve the o
Yes - repeating data can be sorted via the column label e.g. 'Created on'. Clicking in the column header will sort the repeating data based on the header selected - one click will sort to ascending and to change the order to descending, click once again.
Our Professional services team will support and advise you in eCRF design, study build and maintenance, study migration, product training and personal study consultation. Have a look here for an indication of the type of projects we can help with.
Released: 25 August 2021 Added features/functionalities In-person signing eConsent now supports hybrid consenting procedures. Besides the support of remote consent via embedded video calling, consenting can also take place via the in-person signing process. When the subject signs in-person they are not required to create an eConsent account. Study s
Castor Connect 2021.2.0 release certificate is available for download below. Castor_Connect_2021.2_Release_Certificate.pdf
Castor eConsent 2021.4 release certificate is available for download below. The release notes for version 2021.4 is available here. eConsent_20214_Release_Certificate.pdf
There can be multiple reasons your automation behaves differently than you expect. See a couple of explanations below. If this article doesn't explain the behavior of your automation, feel free to contact us at support@castoredc.com. Automations are only triggered if the event is executed This means that if you already have executed the event (e.g.
Castor Connect 2022.2.0 release certificate is available for download below. Castor_Connect_2022.2_Release_Certificate.pdf
When changing to a new mobile device where 2FA is enabled for your account, it is usually necessary to first verify your new device within the Authentication app or temporarily disable 2FA. For example, for Google's Authentication app, you'll need to verify your new device as explained here . To temporarily disable 2FA in Castor, navigate to your A
Castor EDC 2019.1 release and randomization certificate. Release notes for 2019.1 can be found here. randomization_certificate_2019.1.pdf Release_Certificate_2019.1.pdf
Castor EDC 2019.2 release and randomization certificate. Release notes for 2019.2 can be found here. Randomization_certificate_2019.2.pdf Release_certificate_2019.2.pdf
Castor EDC 2019.3 release and randomization certificate. Release notes for 2019.3 can be found here. Randomization_certificate_2019.3.pdf Release_Certificate_2019.3.pdf
Castor EDC 2020.1 release and randomization certificate. Release notes for 2020.1 can be found here. Randomization_certificate_2020.1.pdf Release_certificate_2020.1.pdf
Castor EDC 2021.1 release and randomization certificate. Release notes for 2021.1 can be found here. Release_certificate_2021.1.pdf Randomization_certificate_2021.1.pdf
For English see below Dinsdag 25 augustus 2020 Aanpassingen: In het Gebruikersmenu is het nu mogelijk om gebruikers te selecteren. Op deze manier is het mogelijk om in één keer meerdere gebruikers te deactiveren. De kolomopties 'Aantal te includeren proefpersonen in dit ziekenhuis' en 'Wordt deze studie gefinancierd' zijn toegevoegd aan het algemene
Android release date: 3 December 2021iOS release date: 1 February 2022 Additional fields available in Castor Connect Users can now build mobile-enabled surveys using the summary field Summary fields can display other question responses from within the same submission - for example, you could provide a helpful review screen at the end of your survey
Castor Connect 2022.1.0 release certificate is available for download below. Castor_Connect_2022.1_Release_Certificate.pdf
It is our suggestion, that you think about your data management plan before you begin collecting data. The articles listed below contain suggestions and ideas for managing your data throughout your study. Links to instructions are provided for additional components you may wish to add to your study: Performing UAT Subject enrollment status Complia
Main features & improvements Surveys It is now possible to set up a reminder for a survey package. This can be done when creating/editing the survey package in the structure tab. This is a generic setting for the survey package and will always be applied when an invitation is sent for that survey package. The reminder can be set for up to 99 day
Woensdag 13 juni 2018 Aanpassingen: De taken feature heeft een aantal verbeteringen gekregen, zoals onder andere: De automatische taken kunnen nu ook ingesteld worden voor de speciale goedkeuringsaanvraag- en deelnemende afdelingsrollen. Naast de studietitel wordt ook het studienummer getoond. Het aantal open taken dat wordt getoond in het Takenmenu
Castor EDC 2021.6 release certificate. Release notes for 2021.6 can be found here. EDC_2021.6_Release_Certificate.pdf
Release Date: 4 April 2022 QR Activation You can also now generate and share an activation QR code to enable participants to scan and activate their Castor Connect app. This can be done with the new “activation management” function in the record survey view. Training Surveys Mobile surveys can now be configured as ‘Training’ surveys within the surve
Castor EDC 2021.2 release and randomization certificate. Release notes for 2021.2 can be found here. EDC_2021.2_Release_Certificate.pdf
Release date: 3 August 2021 ENGLISH System defects fixes: For some installs, users are automatically assigned a second user role. This wasn’t always working, and has now been fixed. These automatic role assignments are now also logged in the audit trail. For users that don’t have access to the dashboard, the dashboard was still visible but didn’t sh
Released: 14 December 2021 Added features/functionalities Configurable signatures The needed signature components on the consent forms can now be configured on a form level. Only subject signature Some documents only require a subject signature and no counter signature by a study team member. This use case is now supported by eConsent. The study tea
Castor eConsent 2022.1 release certificate is available for download below. eConsent_2022.1_Release_Certificate.pdf
CastorConnect 2024.x 21 CFR Part 11 & Annex 11 Assessment of Compliance.pdf is available for download below. CastorConnect 2024.x 21 CFR Part 11 & Annex 11 Assessment of Compliance.pdf
Castor Connect 2021.1.0 release certificate is available for download below. Castor_Connect_2021.1_Release_Certificate.pdf
Castor eConsent 2021.2 release certificate is available for download below. eConsent_2021.2_Release_Certificate_(1).pdf
Release date: 21 May 2021 Castor eConsent has undergone a major design update to ensure the best user experience for study teams and their participants. The design improvements create consistency between our Castor products and give flexibility for us to build more exciting functionality. The following study statuses have been added: Testing (Castor
Castor EDC 2021.3 release and randomization certificate. Release notes for 2021.3 can be found here. EDC_2021.3_Release_Certificate_(1) (1).pdf
Release dates: EU server: March 7, 6 PM CET US server: March 8, 10 AM CET Added features/functionalities Single Sign-On support We are extending our user management capabilities with the support of Single Sign-On (SSO), possibility to integrate external Identity Providers (IdPs) via OpenID Connect (OIDC). In this release we commence pilot integrat
Release dates: EU server: June 14, 6 pm CEST / 12 pm EDTUS server: June 15, 10 am CEST / 4 am EDT New features Introducing LAR signature capabilities To better align with user needs, we’ve built the option to include LAR (Legally Authorized Representative) signatures in your eConsent process. This includes a LAR ICF builder component that, when ad
Please note - study submissions can only be approved by system administrators, or when having the required user rights. Approve a study submission Go to the 'Studies' tab. Open a study. Go to the 'Admin' tab. Select the required study status from the "Current study status" field. Click on 'Save' to save the new study status. Depending on notificatio
At the moment you have two options to export audit trails: We can export the file for you against a certain fee. Or you can export it yourself via API. Audit Trail export file provided by Castor To request an export of the audit trail, please contact support@castoredc.com indicating the title of the study for which the export should be prepared, as
Castor eConsent enables researchers and organizations to create and manage electronic informed consent forms for their studies. Before you can start using eConsent, you will need to be granted access and have an admin account created for you. For more information on how to get access to eConsent platform, please check: Castor eConsent and CDMS im
Castor EDC 2022.2 Release Certificate 2022.2_Release_Certificate.pdf
If a subject withdraws consent, follow the forms below: Lock the participant or parts of the participant which should no longer be modified Make sure to trigger an exclusion message - these can be set up in the Data validation tab for a field Archive the participant - archived participant will not be visible in the data entry and will not be exporte
The calculation below allows to check all previous visit dates and compare the date of the last visit with the date of the end of the study. If the last visit date matches the end of study date, the calculation will output 'Yes', otherwise 'No'. '##allowempty##'; '##setemptytozero##'; var screen = moment('{scr_date}', 'DD-MM-YYYY'); var visit_1 =
Castor EDC 2022.3 Release Certificate 2022.3_Release_Certificate.pdf
Learn how to quickly and easily update the email address for survey invitations in Castor CDMS. When creating a participant, data entry users can input email address for the participant. When sending a survey, this email address will then be used to send a survey invitation. You can change the email address in an existing survey invitation. This
Castor EDC 2021.4 release certificate. Release notes for 2021.4 can be found here. EDC_2021.4_Release_Certificate.pdf
To validate whether a year is in the future you can use the following calculation template: var year = moment('{year_field}').format('YYYY'); var year_now = moment().format('YYYY'); if (year > year_now) { "The year cannot be in the future"; } else { "The year is correct"; } Test it here in the calculation helper. Alternatively, you can use th
Calculation fields can be used to validate visit dates. In the example below, inclusion occurred on Sept 1, 2020. For the purposes of this example, there is 7+/-2 day washout. Calculate the Time Between Visits This calculation finds the difference in days between Inclusion and Baseline. Since the is a 2 day window, if baseline occurred less than 5
Yes, our eConsent platform supports the inclusion of knowledge checks within the Informed Consent Forms (ICFs). This feature, known as “Participant Questions,” allows the incorporation of radio button questions directly into the ICFs. Participants can easily interact with these questions, selecting their responses from the provided radio button opti
The following PDF files include role-based instructions for Castor eConsent. You can download or print these files for your own documentation: eConsent Organization Admin User Guide 2023.2 eConsent Study Admin User Guide 2023.2 eConsent Site User Guide 2023.2 eConsent Participant User Guide 2023.2
Release date: 19 April 2022 New features and / or enhancements Possibility to set test records limit per study basis We’re introducing new internal tools to facilitate the testing of not live studies. Survey field to capture location from the browser API We added a new field type to surveys with the capability to use the web browser Geolocation API
Release date: 19 May 2022 System defect fixes Disable cascading SDV logic for specific types of form structure import We've fixed a defect on import regarding cascading logic for SDV, that sometimes caused errors while trying to create a linked study using Form Sync, as well as while importing a structure to an empty study. Step being marked as SDV
Study admins can define a custom date format for each institute in the Settings tab. Alternatively, it is possible use calculations to change this format by getting the day (dd), month (mm), and year (yyyy). In this article examples are shown that you can use in your calculation templates. We'll use the date 30 January 2025 as an example throughou
In Castor, there are two separate randomization permissions: Randomization - a user can randomize patients (participants) View Randomization - is necessary to see to which group a participant has been allocated Each of these rights can be assigned to different roles and sites. The user with Randomize rights only will see the date of randomization a
Woensdag 17 april 2019 Aanpassingen: Documenten: Vanaf nu wordt er een onderscheid tussen het normaal verwijderen en het definitief verwijderen van een document. Een nieuwe map "Verwijderde documenten" is toegevoegd aan het studies tabblad; Bij het (normaal) verwijderen van een document komt dit document in het "Verwijderde documenten" map terecht;
Castor EDC 2021.5 release certificate. Release notes for 2021.5 can be found here. EDC_2021.5_Release_Certificate.pdf
The Castor SMS 2021.6 release certificate is available for download below. Release notes for 2021.6 can be found here. SMS_Release_certificate_2021.6.pdf
Castor Connect is Castor’s mobile application, enabling participants to complete their study assessments (‘surveys’) from the comfort of their personal devices. Castor Connect is a paid feature, please contact us via support@castoredc.com if you would like to enable this for your study. If you are using web browser based surveys, below you will fi
The Castor SMS 2021.7 release certificate is available for download below. Release notes for 2021.7 can be found here.
When using a text field , you can use the following template to check whether the field contains any numbers and display a message of your choice. Create a calculation field in the study form using the calculation field example below - remember to replace 'variable_name' with the variable name for the text field. You can also update the messages s
Castor eConsent 2022.2.0.0 release certificate is available for download below. eConsent_2022200_Release_Certificate.pdf
Castor SMS 2022.2 release certificate is available for download below. SMS_Release_certificate_2022.2_signed.pdf
Each survey contains single or multiple forms which will appear as a different page in the survey. Users can navigate through forms using the Previous/Next buttons. You can add Forms to a Survey under the ‘Study Design’ as shown below: Similarly to the forms within the study CRF, you can then group the survey questions in different forms at your
Study admins can define a custom date format for each institute in the Settings tab. The calculation template below can be used to convert a date field entry into CDISC format (dd/mmm/yyyy). For example, if 30-01-2025 is entered into the date field, this calculation will convert the entry into the new format, such as 30/JAN/2025. Replace your_da
Our current services availability can be reviewed on the Castor Status page: https://castorstatus.com/ Although we aim to keep downtime to a minimum, users may occasionally experience trouble connecting to one of our servers. We truly believe that reliability and up-time are critical to our customers. To show our commitment, we’re launching this sta
If your organisation has an institute contract, you may contact your local Clinical Trial Unit (institute/organisation Research Department) to request the billing code. The Billing Code may also be found on the intranet page of the institute, where applicable.
tabFlexible date formats gives users the possibility to define, per each available study site, the preferred date format to be used and displayed within data entry. To define custom date format, follow the steps below: 1. Navigate to the Settings → Study sub-tab → navigate to the ‘General’ section 2. Click on the ‘Manage sites’ button. On the ‘
Yes - the Monitoring module in Castor allows the study monitor to create, manage and resolve data queries in the study. You can learn more about monitoring queries here.
If you want to check whether certain fields are filled in, you can use the template below. In this template, there are 2 fields: Variable name Field label dem_pat_gender Gender dem_pat_yob Year of Birth Replace the labels and variable names in the template with your own. '##allowempty##'; var req_labels = ["Gender", "Year of Birth"]; var req_fiel
Great that you are citing us, we really appreciate it! We suggest the following: Data was collected using Castor EDC [1] [1] Castor EDC. (2019). Castor Electronic Data Capture. [online] Available at: https://castoredc.com. For convenience, we have attached the Endnote citation file, you can download it below. CastorEDC.zip
Castor uses a validated variable block randomization model. This randomization algorithm is constructed in such a way that randomized inclusions are divided across groups (with optional stratification) in variable block sizes. This is done to ensure true randomness during the allocation. You can define your groups and choose the block sizes in th
CastorConnect We are excited to announce that we will soon launch CastorConnect! CastorConnect supports clinical studies by providing patients access to surveys and questionnaires on their mobile devices. Are you interested? If you are a researcher interested in CastorConnect for your study please contact us through sales@castoredc.com. Are you are
Yes, it is possible to enable two-factor authentication (2FA) via any Authentication app that supports TOTP, e.g. Google Authenticator, Authy, etc.). Please note that two factor authentication is activated per account (user). Two-factor authentication is account-based or study based. Some studies require two factor authentication from users. The p
' Consent Forms' overview The 'Consent Forms' page displays the names, versions, and other relevant details of the consent forms. From here it is possible to create new consent forms and manage existing ones. Name: the title of the consent form. Version: the current version of the consent form. Consent method: based on the signature method, two opt
Delete a participant If you are not yet collecting data and your study has never been set to live, you can delete the participant. To delete a participant, click on the 'Participants' tab, then click on the three dots next to the participant you want to delete. Then click 'Delete': All the participant IDs that are deleted will get the prefix DELETED
No, it will not. Automations are linked to visit/form and field IDs. The automations will continue working, even after changing the name of the form or visit, as well as any field labels.
There are many CTIMPS trials running in Castor EDC/CDMS. Castor EDC/CDMS complies with all applicable medical data privacy laws and regulations: Good Clinical Practice (GCP), 21 CFR Part 11, EU Annex 11, and the European Data Protection Directive. Using Castor EDC/CDMS, researchers can comply with all GCP guidelines applicable to them in their role
You can copy an entire survey by clicking on its cogwheel in the 'Study structure' tab: You can also copy single survey forms into the same or another survey. This will copy all the existing fields in that form. Go to the 'Surveys' sub-tab in the 'Study structure' tab. Select the survey from which you want to copy forms >> Find the form to
At Castor we have developed a series of videos, webinars and other resources that will help you become a Castor pro. Have fun! Castor Academy The Castor Academy contains a structured series of videos with step-by-step instructions for each selected Castor feature. Watch the video below to learn more about the Academy and visit this link for a quick
We offer a wide range of resources to help you get started with Castor EDC/CDMS: Knowledge base for step-by-step instructions Castor Academy for role-based video tutorials Customer support to answer any questions you might have Our Professional services team will support and advise you in eCRF design, study build and maintenance, study migration, pr
To support your projects in Castor EDC/CDMS, Castor eConsent, Castor Connect, and Castor SMS, we provide several service levels. Learn more about our Service Level Agreements here.
Castor CDMS allows a PI to sign each visit, form, and repeating data instance. Often times, it is only required that the PI signs the participant once a subject is discharged from a study. If the latter is the case, it is an option to add an "End of Study" visit to your study. Here you can collect the reason for the subject's discharge (discontinu
The standard address from which surveys are sent is no-reply@castoredc.com. This will always appear as the sender email address. When you select a user email address as the sender, the participant (receiver) will still receive an email from no-reply@castoredc.com, but the name of the user will appear as sender. In addition, the survey participant
Videos can be an effective way to convey important information to participants, and our platform facilitates the integration of videos into the ICFs. Currently it's possible to add a link to a video. To add a video, simply use the "Insert/Edit Link" option available in the "Form text" section while creating or editing an ICF. Follow these steps: Cli
It is possible to randomize your test participant(s) to check if the randomization settings you have chosen are working correctly without concern over influencing the data you will collect later. As long as your study has not previously been set to "live" or is not currently live, you will be given the option to reset the randomization in your st
If you want to extract a part of a date and time field (i.e. the date only, or the time only), you can use the following templates. Replace {your_datetime_variable} with your own variable name. To extract a date from a date and time field: var splitted_datetime = '{your_datetime_variable}'.split(';'); if(/^((0?[1-9]|[12][0-9]|3[01])[-](0?[1-9]|1
Major release 2022.1.0.0 Release date 22nd March 2022 Added features and/or functionalities Records The Record Status has been added to existing Audit trail events related to records. This is logged & stored statically, to ensure an accurate view of all the relevant details of a specific record. We've also included the status to existing endpoin
Please note - institutes can only be managed by system administrators. Institutes/sites are managed from the 'Institutes' tab. Institutes can be linked to both users and studies. Add institutes/sites: Go to the 'Institutes' tab. Click on 'New institute'. Complete the required fields. Click on 'Save' to add the new institute. Add departments: Go to '
Elk ziekenhuis/instituut heeft een Castor SMS omgeving met een eigen webpagina/URL. Om de demo versie van Castor SMS te bekijken ga je naar: demo.castorsms.com, je kan inloggen met je Castor account. Aanmaken profiel Nadat je voor het eerst bent ingelogd kom je in je profiel pagina terecht. Vul de verplichte velden in en klik op 'Opslaan' om door te
Follow the steps below to update your email and confirm the change: Navigate to Account Settings Log in to your Castor CDMS account. Click on the Account icon Go to the Settings section from the menu. Access Email Settings: In the account settings, click on the Email Settings option. Enter Your New Email: In the provided text field, type in y
We are excited to announce the launch of the Form Sync feature! This feature enables users to easily add, delete or edit their forms in the test environment with test records, and invite users to review the revised CRF, all without impacting the production study. Our FormSync feature allows for each production study to have a corresponding test env
On Friday December 10th 2021, Castor became aware of a critical severity zero-day exploit known as “Log4Shell” in the Log4j library, which is widely used in numerous systems, websites, applications and digital services. We reacted immediately and triage determined our services were NOT affected. Subsequently, on Tuesday, December 14th 2021, and Satu
Yes, calculations can be used in your surveys. This is done in a similar way to the calculations used in study forms. The survey calculations can only refer to variables within the same survey, and therefore survey calculations cannot reference study or repeated data variables. You can also use the participant metadata, such as the participant ID a
Comparing two variables In calculations, you sometimes need to compare two variables against each other. Check out the article Using the "if-else" logic to see how this works. For example, you want to check if one value is larger than the other and then show an error message if the condition is true. Below is an example that allows you to check if
Please note - notifications can only be managed by system administrators. It is possible to configure automatic notifications for specific events. These email notifications are sent from no-reply@castorsms.com. Email notifications are triggered by events - these can occur within the study flow, study specific events and user related events. Disabled
1. Create a calculation field after two date fields. You can choose the variable names yourself, but you will have to change them in the calculation template in step 2. In our example, we will check if the Visit 1 (variable date2) date is before the Screening Visit date (variable date1) 2. Use this formula for the calculation field: //Is date 1
Using calculation fields, it is possible to check if a patient fullfills certain inclusion criteria. Below is an example that checks whether a patient has signed informed consent (variable {INCL01}), has participated in the trial before (variable {INCL02}) and whether the age requirements are met ({INCL03}): if ({INCL01} == 1 && {INCL0
For English see below Dinsdag 30 juni 2020, versie 20202.13 Aanpassingen: Gebruikers menu: Er is een snelheidsverbetering doorgevoerd waardoor de gebruikers sneller worden geladen. Het is vanaf nu inzichtelijk op welke datum gebruikers voor het laatst zijn ingelogd in de Castor SMS omgeving. Let op: alleen data van na 8 augustus 2019 worden getoond.
The Studies overview provides a list of all the studies you have access to. This overview consists of 3 separate views: All studies (1), Favourite studies (2) and Last opened studies (3). 1. All studies: All the studies you have access to are listed here - this is the default view for the ‘Studies’ tab. Display: Horizontal scrollbar: The width of th
You can find the client ID and secret in your Account Settings in Castor. You can access your Account Settings from the blue bar, hover over 'Account', then click on 'Settings'. Find your user credentials in the tab "Castor EDC API" subtab. When you regenerate your client secret, then your 'older' secrets will become invalid - i.e., make sure th
Main features & improvements Design updates A new navigation menu Access for Account Settings and other support links has now moved to the left side and is expandable:All tabs within the study and sub-tabs have also moved to the left side, which allows for more vertical space. A main contact page is added, this is visible in the navigation for u
Study roles with PII access (i.e. study investigators/monitors) will see an 'Export' button on the audit trail page they can use to run the export. A pop-up window will appear, click ‘Generate’ to run the export: Only audit trail events for which you have view rights will be included in the export file. You will receive an email notification
You can use the Study Dashboard to track the progress of your study, including participant recruitment, data collection progress, queries and randomization. The Study Dashboard is a beta feature which is being tested with a selected amount of users. More on this can be found here: The Study Dashboard in CDMS
The attached document provides an overview of the functional and technical aspects of the Castor EDC encryption module. Encryption_Module_Collateral.pdf
Custom columns can be created to show specific variable values in the Participant overview. For example: Manage custom columns Custom columns can only be created by users with "Manage Settings" rights. Navigate to the Settings page then go to "Other" tab. Click on "Manage custom columns" in the ‘Participants overview custom columns’ field. A dial
Castor is making medical research faster and smarter. As part of this, we pride ourselves in exposing extensive APIs to our products’ functionality and data having some of the most advanced APIs in our industry to enable you and your engineering teams to fully harness the power of our software. To further these goals, we’ve crafted the Developer Pol
Add a new study Go to the 'Studies' tab. Click on 'New study'. Fill in the required fields. Click on 'Continue' to add the study. The new study will then be added to Castor SMS. Before the study can be submitted, all required fields and required documents must be uploaded. For more information, refer to the ‘Check & submit’ tab of the study.
Participants can register their interest in the study through a customized enrollment page, after which they receive an email prompting them to sign up in the Castor eConsent portal. Alternatively, identified patients can be invited directly by the study team (through email) to sign up for eConsent. Participant registration and eConsent access Wh
Castor SMS data can be exported into Excel. Exporting of data Go to the 'Studies' overview. Click on 'Export'. Select an export option. A predefined export report. A custom made export report via 'Extended export'. Select the fields you want to include in the export. Click 'New preset' to save the exported report. All study data you have view rights
SDV and Signatures are similar measures to mark a form or visit as having valid data entered, being complete, and/or having been checked by a monitor. Source Data Verification (SDV) - confirms the conformity of the data presented in case report forms with the source data. It is possible to perform SDV on a field, form or a visit. Other Data Veri
Before you start: A user must have ‘Site Admin’ rights in order to create participants. Please note that the users with the ‘Study Admin’ rights will not be able to create participants. Adding a participant To create a new participant in your study, follow the steps below: 1. Navigate to the ‘Participants’ listing 2. Click on the ‘Add participant’ b
This article provides an overview of errors you might find in your calculation field in data entry. The most common reason for calculation errors are mistakes in syntax (in the calculation template). You can check your calculations using the Castor Calculation Helper - this tool can help identify syntax errors and incorrect references in calculation
Each study is identified in the database by means of a unique study ID. The name of the study is only an external label. Changing the name of the study will therefore not affect the structure or data of the study, even after going live. You can change the name in the settings menu of your study:
The current status of a study is visible on the Studies page, as well as when opening an individual study. See eConsent: Studies Overview for more information. Each study progresses through the following statuses: Testing (Castor): The study is being tested by Castor. Audit trail events during this study status are marked with the status 'Testi
Castor EDC/CDMS has an Application Programming Interface (API) that supports authentication and authorization of API calls through the industry standard OAuth2. Learn more about the API in this article: Castor EDC/CDMS Application Programming Interface (API) All documentation for the API can be found on https://data.castoredc.com/api. If your stud
Participants are subjects who are invited to the study. Selecting the ‘Participants’ tab, a listing of all participants (participants) that you have access to, based on your role and sites, will be listed. Participants Overview From the 'Participants' page you can add new participants to your study and manage the existing ones. Only site admins
Yes, it is possible to map your Electronic Medical Record to Castor. You can also import CSV files with data directly into Castor EDC using our import functionality. Once you have built your eCRF, you can export an empty csv file, add your existing data to the exported file and then import the completed file into your study. It is also possible to
De vragen (velden) in Castor SMS zijn gegroepeerd in een aantal algemene tabbladen. De algemene tabbladen zijn: Basisgegevens - Hier wordt algemene informatie verzameld over de studie, zoals studietitel, samenvatting van de studie, de verrichter en of het een mono- of multicenter studie betreft. METC - Hier wordt informatie verzameld over zaken die
The Castor SMS 2021.5 release certificate is available for download. Release notes for 2021.5 can be found here. SMS_Release_certificate_2021.5_signed.pdf
Let op: Dit artikel is alleen van toepassing voor gebruikers met een Admin rol. Er zijn 2 manieren om nieuwe rollen aan te maken: handmatig en automatisch. Dit onderdeel van de handleiding gaat over het maken en beheren van handmatige rollen. Klik hier om naar de handleiding over de automatische rollen voor deelnemende afdelingen en goedkeuringsaanv
You can send survey reminders to participants who have not yet completed their survey after a certain period of time. Discover how to quickly and easily trigger survey reminders in Castor CDMS below. Automatic survey reminders It is possible to set up an automatic reminder when creating/editing survey package. This is a generic setting for the surve
Completing survey via a web browser If you do not have the email address of the survey participant or you want the respondent to directly fill in a survey during a visit on site, you can still use the survey module without sending actual email invitations to the participant. You will still have to create the survey invitations for the participant (p
Yes you can. There are two ways to add a link to a website in a survey. You can use the "Finished URL" box in the invitation to enter an address that will redirect the participant to a website when the survey ends. You can add an internet address to the invitation email inline by using this format: [example link]( http://www.example.com/ ) This way
Time fields in Castor only capture hours and minutes. If you want to capture time in the format HH:mm:ss, you need to use text fields. However, you can calculate with those as well! To calculate the difference between two text fields where you are capturing time as HH:mm:ss, you can use the following formula: var timePoint_1 = '{time1}'; var timePoi
To import data from your institute's Electronic Health Record (EHR), the study fields must first be configured to be able to map the incoming data to the right forms and fields within your study. Follow the steps below to configure fields for importing of EHR data: 1. Your study must first be configured by Castor to allow linking to the EHR. 2.
The User & Roles page displays the names, emails, roles, and sites for everyone with access to your study. From this page, it is possible to revoke access, view pending study invitations, and re-send or cancel invitations. Search bar: allows searching for a user based on the full email address Name: Displays the name of the user once they have
This document applies to Castor eConsent version 2021.x.x as internally developed and tested. Castor eConsent has been designed and developed to be in compliance with 21 CFR Part 11, electronics records, electronic signatures and predicate rules when implemented and controlled effectively by the System User. Castor achieves compliance through a comb
The instructions described in the article Calculate with grid fields renders the objects in string (plain text). If you want to do mathematical operations with numbers, you will need to convert that text into numbers. For that you would use the parseInt() function. Calculate the sum of a row within one grid For example, we want to get the sum o
Learn how to change your account settings in this tutorial. You can access your account Settings via the Account button at the bottom left of the navigation bar, visible when you are logged in to Castor CDMS: When you click 'Settings', you can view and change your profile details, account details and user details: In General details, you can add and
Castor CDMS uses the decimal point (dot). Decimal commas should not be used, i.e. instead of 3,14 use 3.14.
Any customers wishing to access upcoming releases in our UAT environment need to be invited upon request. Please reach out to your Account Manager to request access. Castor CDMS offers a separate User Acceptance Testing (UAT) Environment. The purpose of the UAT environment is to test the upcoming release ahead of time in order to accustom with new f
Castor is secured according to the most recent standards to make sure your data is protected in the best possible way. The measures we take to protect the data are outlined in our Security Statement. While we strive towards storing the collected data as securely as possible, as a user you also play a role in keeping this data safe. Accessing the sys
Calculation fields in Castor allow you to solve different mathematical problems by using the variables from your eCRF. Common applications of calculations Calculations can be used for simple mathematical operations, such as calculating the body mass index from two variables - height and weight. The calculation fields can also be used for more comple
If your institute has mapped the local Electronic Health participants (EHR) to Castor, you will be able to transfer the data from each EHR to the appropriate Castor participant using a FHIR importer, which you will need to use regularly to import the data. To be able to use the Importer, the study must be configured to allow for receiving or acti
Admin users can add templates to Castor SMS for letters, which include study variables. When downloading such a letter template from a study, the entered values from the system will automatically be imported into the letter. Steps: Open the study and navigate to the "Templates" tab Click on the download icon or right click with your mouse to downloa
If your institute has mapped the local Electronic Health participants (EHR) to Castor, you will be able to transfer the data from each EHR to the appropriate Castor participant. Castor uses a FHIR importer, which you will need to access regularly to import the data. There are several prerequisites for using this functionality: Your institute has e
The calculation helper tool is used to check the syntax and output of your calculations. You can find the calculation helper by clicking on the Support button: In the tool page you will see different buttons and sections: Define your variables: In the field on the left you have to define the variables that you are going to use (see the example). In
With the CDMS 2022.3.0 release scheduled for August 2022, we will be introducing terminology changes to better match those more widely used in the industry. By using terms more familiar to our users in Castor EDC, we aim to improve the learning curve and overall experience on our platform. The API endpoints won’t be modified yet, we’ll announc
See here how you can add a month to a date: Add a month to a date. Use this template to subtract a month from a date. Replace {date} with your own variable name. var date = moment('{date}', 'DD-MM-YYYY'); var newDate = date.subtract(1, 'months'); newDate.format('DD-MM-YYYY'); Test this template in the calculation helper. If you want to use dif
It is possible to lock participants in Castor, which will prevent other users from accessing them and making changes to the data. Only users with the 'Lock' user right can lock/unlock a participant. Once a participant is locked, it cannot be signed. Your browser does not support HTML5 video. To lock an individual participant, navigate to the 'partic
Calculation fields in Castor are often used to build advanced date validations. In Castor dates are stored as string (text) in the format 'DD-MM-YYYY'. It is generally necessary to indicate this in your calculations. For this you can use the so-called 'Moment' function in JavaScript. Moment.js is a JavaScript library that offers many possibilities t
In Castor it is possible to import data captured with other tools. The article Import study data provide an extensive explanation of the preparation of the datasheet and the forms to import it in Castor. This article outlines some specific data formats that you need to be aware of when preparing your data for import. Importing option group data: rad
A guide to practice testing your automations and become familiar with the automation's behaviour. In order to complete this tutorial, you must have at least one existing automation. If you don't have an automation, try creating one! Review your automations First, it is important to review your automation in the Automation Overview, taking special no
Participants are required for data entry in Castor. If you have not yet created any participants, you must complete this action first. This article explains how to create a new participant in Castor. You can also learn more about data entry within Castor Academy. Click here to view the Castor Academy ‘ Data entry in Castor EDC-CDMS - Certifica