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Castor CDMS 2023.4.x.x Release notes

Major release 2023.4.0.0 - Release date 25th October 2023 

New features and / or  enhancements

Surveys - clinician view

  • We are introducing a new slider field within the CDMS form builder. This is currently available in correlation to the new survey experience only. More details are available in our revised slider field article here.
  • The new slider field has a number of validations in place in the form builder to prevent users from configuring illogical or breaking sliders, including:
  • no more than 100 steps or ticks are permitted
  • top and bottom bounds of the slider must be consistent in terms of decimals
  • As new slider configuration options are only available to surveys, we block copying of survey forms with sliders to visit or repeating data. Sliders are now configurable based on additional criteria added to the form builder. 
  • When turning GCP on for their studies in the Settings page, studies will have 3 options for how their clinicians are prompted to enter a 'reason for change' when editing submitted survey data: 
  • Require a reason for change for all / any revisions (with a 30 second buffer for editing the same field);
  • Require a reason for change for the first edit made to a form, and re-use that same, editable reason for change for all subsequent edits to that same form during the current session; 
  • Do not enforce a reason for change at all.
  • These new options for configuring the way 'Reason for change' is checked for survey data will be displayed on the study settings screen when modern web surveys are enabled.
  • The reason for change provided by users for editing data contained in a survey, repeating data or study visit form will now be stored as part of the field update in the audit trail, rather than as its own 'comment' event.

Web surveys - participant view

  • An overall survey package progress bar has been added to the navigation bar, and will persist even when the participant is not allowed to navigate between pages.
  • The study logo and language picker will now be contained within the top of the navigation bar, or the 'survey summary block'.
  • Field status indicators were updated in the modern web survey view to be clearer to users.
  • Web surveys have been updated to split lines appropriately when words reach the width limit of a field. Fields and web survey components now scale to suit the user's screen.
  • We have added the ability to switch between legacy and modern web surveys to the settings screen for all existing studies. A warning message for studies where legacy UI may have been validated or submitted for ethics review to inform users before migrating has been included. More information regarding the new web surveys can be found here.

Randomization  

In the redesigned randomization settings view 

 

  • We have preserved all previous features and functionalities and have rearranged the elements for an improved flow.
  • All available inputs for the variable block randomization in the settings have been redesigned, without any changes in functionality. All are read-only and an info text is shown when study is or was previously set to live.
  • Users with required permissions can add, update and remove randomization groups from the newly designed page for the randomization settings, using a dedicated table. To manage the stratification factors, a second  dedicated table is present for these
  • Changes made in either of the tables are persistent while the user is on the same page and before reloading the page. 
  • To save the changes made in the randomization settings, the entire randomization page needs to be saved in order to cross-check the validity of all selected settings.
  • Users can update the changes by clicking on the Save button in the page’s lower panel as long as the study was never set to ‘live’. Once the study was set to ‘live’, the Save button is disabled and informative text is shown under the page's title.

 

In the redesigned participant randomization view

 

  • In the existing Participant summary block, a new icon for Randomization has been added. This will be visible for studies that have the Randomization feature enabled in the study’s settings and will account for the logged in user's permissions.
  • If the user has View rand. permissions granted, but the participant has not yet been randomized, the label next to the icon will show 'Not randomized'.
  • If the user has View rand. permission granted and the participant has already  been randomized, the label next to the icon will show the name of the randomization group (ie 'Control')
  • If the user does not have View rand. permission, the label next to the icon will show 'Hidden'.
  • If the user has either  View rand.,  Randomization or both permissions granted, the icon will be actionable and more information will be presented in a modal dialog
  • Clicking on the new randomization icon will open the Randomization information modal dialog. The participant's randomization flow is presented with a modal dialog. 
  • When the study does not have the randomization settings (properly) configured, the modal will display an informative text. Users with Manage settings permissions will be able to jump directly to the settings page from here.
  • When some of the all fields required to randomize are not available then the first section of the modal shows a static  informative text regarding this and the button to randomize is not available.
  • When all fields required to randomize are available, the layout and inputs shown in the participant randomization modal are reflective of this: the first section of the modal shows a static text and the 'Randomize' button is presented. Only users that have Randomization permissions for the participant's site can click on the button. If the user lacks the required permissions to randomize the participant, the button will appear as read-only.
  • If the participant is excluded, the Randomize button is not available to the user and an informative text is being presented regarding this.
  • All field labels and field values  presented to the end user that are found on any structure elements configured to be hidden for the user’s role are shown as 'Hidden'. The same label is used in the Status column when this scenario is applicable.
  • When the participant has been randomized, the section "Randomization allocation" shows all randomization allocation details, while the section' Required fields' will be hidden, as was the case in the old designs as well. The 'Randomize' button is not shown any longer.

Miscellaneous & UX

  • The reset PIN email sent from CDMS has been updated to include additional languages.
  • The reset flow for Castor Connect has had the text updated to more accurately reflect the actions required of clinicians and participants.
  • We have updated the "/study/{study_id}/export/data" API endpoint. The endpoint now takes blinding rules into account when exporting the data.
  • We have updated data entry functionality so that after clearing the value of encrypted fields, they are noted as incomplete for data entry progress and added a hidden value to encrypted fields recording whether it has a value stored or is empty for the purposes of calculations/monitoring elsewhere in the platform.
  • We have changed the term 'rights' to 'permissions' throughout CDMS. More so,   the Permissions overview (previously Rights overview) in the User tab, now displays role-level permissions. Each site's users are listed, along with their role assignment, 2FA status, last login date and time.
  • We have added an additional check upon deleting a role. A role cannot be deleted if it is assigned to one or more user(s).
  • We have optimized the row expansion capabilities for improved performance on the participants overview, to better accommodate studies with a large number of forms that need to be displayed. 
  • For users with 'Archive' permissions for the selected repeating data listing, the auto-dismissed warning toast  on the global overview, shown when attempting to open an archived instance, will  now display an actionable option to directly unarchive that instance.
  • We have exposed the "Site" column on the global repeating data listing. The column can be sorted alphanumerically.
  • We have updated the copy of the information text displayed under the billing code input to include a link to an external form.
  • We have made a series of general UI/UX changes, such as
  • updated empty states of various views such as participants, repeating data, updated copies of the text in other parts of the system, such as modal dialogs and changed the design of some inputs such as the text input
  • aligned error messages regarding  lacking 2FA settings, to ensure the same experience is available even if the study settings are updated on the fly, while some study users are already logged into a study.
  • added some animation to our toast notifications, to help draw attention to the top right corner
  • updated lock /unlock icons
  • aligned header behavior on global listings for consistency and better usability on smaller screen sizes
  • presenting the "Study ID" input in the settings as a simple text and the user can easily copy to clipboard the entire ID string, by using the new icon

System defects fixes

  • We have addressed a labeling issue in the Form Sync workflow that showed deprecated terms like Phase instead of Visit.
  • An issue was fixed that allowed users with 'Encryption/Decryption' management permission to be imported by another study user that did not does not have the same set of permissions enabled.
  • We have addressed an issue on the user import, where the system did not throw an error if the import file contained users with assigned 'Encryption/Decryption' management permissions, but the user importing did not have the equivalent set of permissions enabled. Now, an error is shown if the importing user is not allowed to update all of the permissions found in the import file.
  • We have fixed an issue in the Audit trail filters. The "Permissions - User access revoked"  event was not visible, nor selectable from the Event type dropdown. Now this event is present for all studies in the mentioned filter option.
  • We have resolved an issue where, when updating repeating data instances in bulk via the data import feature, the repeating data parent was not updating as expected.
  • We have fixed a defect in the Add/Edit Field modal where the 'Required' property found in the 'General' section would sometimes not be saved, when changes were made in a different section.
  • We have fixed a defect related to account activation, where user accounts were activated before the entire registration process  was completed.
  • We have addressed an issue that sometimes caused the tree view in the Form Structure and Data export modals to not populate with the study's information. 
  • We have fixed a defect related to the rounding of field upper limits above '99999999'.
  • We've fixed a defect related to role assignments not being deleted upon deleting a user from a study.

 

Known release limitations 

New slider fields

  • Users who build sliders within the new web survey experience will not be able to import them back to the legacy solution without losing part of their configuration. This is because the new sliders contain options that did not/do not exist on the legacy version

Sorting on columns

  • Subsequent label changes on name or title occurring on the fly may interfere with the sorting logic of columns. If this is experienced, we recommend using the filter option for more accuracy. 

 

Hotfix release 2023.4.0.1 - Release date 6th November 2023

  • We have improved the performance of the loading of feature flags (i.e., switches that allow Castor to turn specific features on or off for specific studies).

 

Hotfix release 2023.4.0.2 - Release date 9th November 2023

  • We have further improved the performance of the loading feature flag information, particularly for large studies.

 

Maintenance release 2023.4.1.0 - Release date 9th November 2023

Role-based access control

  • From this release on, it is no longer possible to set rights at the user level; instead, it is only possible to set permissions at the role level to increase efficiency and security. This means that roles will be the only mechanism to assign permissions, and assigning and overriding permissions at the user level will not be possible anymore. 
  • Current user permissions have been automatically migrated to roles. For permission deviations for currently assigned roles, new roles have been created. If there were no permission deviations for a specific role, the current role remained assigned. Generated roles inherit the name of the existing role as well as a concatenated list of actual assigned permissions between brackets, for example, "Admin (edited: Add, View, Edit, Email, Rand.)".

 

User Management

  • The design of the Users tab has been updated. Users' site assignments can now be seen at a glance, and a new ‘Actions’ and kebab menu has been added. 
  • Filtering options have been added to the Users tab. You may now filter users by role, management permissions, invitation status, and 2FA status.  In addition, the users list may now be filtered by email address.
  • We have updated the text displayed in the 'Reinvite user' dialog.
  • We have updated the design of the 'Remove user' modal and introduced an additional check when a user is trying to remove themselves from the study.
  • The invite and edit user modals have been changed. When adding or modifying a user, you can now assign roles and management permissions.

 

Roles & permissions

  • A new Roles & permissions page was added, where one can see an overview of current roles and assigned permissions to these roles. 
  • The new Roles & Permissions page now includes an edit view. You can update the permissions assigned to roles, edit the name and description of roles, as well as delete them.
  • We have added an additional check upon deleting a role. A role cannot be deleted if it is assigned to one or more user(s).

 

Encryption

  • In the new Users and Roles & Permissions pages, we've added a prompt asking you to re-enter your password/re-authenticate using SSO when performing actions related to encryption/decryption.
  • We've added constraints to assigning and unassigning roles with Encryption/Decryption permissions: these roles can only be assigned if the current user has encryption/decryption management permissions.

 

Print

  • The Permissions Overview (previously Rights overview) in the User Management tab, now displays role-level permissions. Each site's users are listed, along with their role assignment, 2FA status, and last login date and time.

API and import

  • We have removed the option to get and set individual permissions of study users through the study-user API endpoints and user import, in line with our changes to role-based permissions. Instead of passing specific permissions for each site, you should now pass a role per site.

Terminology change

  • We have changed the term 'rights' to 'permissions' throughout CDMS.

 

System defect fixes

  • We have fixed an issue related to camera questions for repeatable surveys in Castor Connect.
  • We have fixed a performance issue related to multiple users being active in data entry for the same participant, or when a user switches between forms before the current form finishes loading.
  • We have fixed an issue where summary fields would display database labels for unfilled variables/fields
  • We have fixed an issue where the 'Cog wheel' or action menu for fields was not triggering as expected for grid fields.

 

Hotfix release 2023.4.1.1 - Release date 10th November 2023

  • We have fixed an issue regarding loading of users on the Users page for large studies with large number of users and/or sites.

 

Hotfix release 2023.4.1.2 - Release date 21st November 2023

  • This release includes minor updates to support Castor's internal processes.
  • We have significantly improved the performance of printing individual forms, visits, and repeating data instances for a participant.
  • We have resolved an issue where newly configured sliders in the modern survey view were inconsistently accepting values at the highest/maximum number available on the slider

 

Hotfix release 2023.4.1.3 - Release date 24th November 2023

  • Minor update(s) to push notification functionality not visible to users to facilitate troubleshooting

 

Minor release 2023.4.2.0 - Release date 12th December 2023

New features and / or enhancements

  • On the Participants, Queries and all Verifications listings, you can now use a new filter for sites that allows grouping by country. The default remains on the list view, but you can now choose to change it to a tree view, to better accommodate your specific needs to group and select site(s) by country.  
  • The nested checkboxes used in the Dashboard have been updated and are now in line with other filters.
  • We have restyled the filter panels in CDMS to improve consistency with recent interface changes. In the same time, we've slightly reordered the available filters on the Participants overview to better convey their similarity. For example, all date related criteria are found one after another.
  • We have updated the copy of the text in the Data export modal to better contain pertinent information.
  • On views with tables, the total number of available pages can be suddenly reduced due to applied filters or actions (for example after bulk archiving of participants). In these cases, the user is automatically redirected to the last available page.
  • While using drill down from the dashboard, the user might need to return to the starting point. To better accommodate this workflow, we no longer load the first tab automatically, but we redirect the user to the tab they have used last.

Study Structure

  • We have added the option to define a footer for modern surveys and survey forms to the Add/Edit Survey and Add/Edit Survey Form modals in the Study Structure tab
  • These footers will be displayed in modern web surveys and Castor Connect (pending release 2023.2 of Castor Connect)
  • The date and time a survey package was sent are now available for use in calculation and summary fields. Including them will allow the display of the relevant survey package’s  'available from' date and/or time within the field
    • e.g.  ‘This survey was sent to you on (surveypackageavailablefromdate)’ to clearly indicate to the participant when a survey was originally made available for completion.’

User Management

  • We've added an option in the 'New user' modal to select all current sites, allowing you to assign all current sites to a user's role. 

Survey Management / Compliance

Castor has begun development of a new and improved survey data listing, the Survey Compliance Listing, that will become available for pilot usage as part of release 2023.4.2; the new listing includes:

  • ‘Compliance’ as a measure, calculated based on the number of surveys completed by a participant compared to the number made available to them to date
  • All of the existing individual survey and participant group actions from the existing listing - including: sending, resending, editing, column controls and filters
  • A ‘combined grid’ showing both participant-level compliance, and individual survey packages listed underneath
  • Filters for site, participant ID, status, availability, submission method, compliance‘Quick filters’ for showing only non-compliance participants or recent surveys with a single click
  • An additional overall  ‘Compliance’ number displayed on the participant listing and within the individual participant summary block
  • Access to this feature can be requested on a pilot basis for customer studies pending full release in a subsequent major release of the platform

Removed features and / or functionalities 

Survey packages will no longer update to the 'Viewed' status in the UI when viewed by a clinician instead of a participant in CDMS as part of our move to further expand clinician-led events and participant-led events

System defects fixes

Verifications

  • We have addressed an SDV related defect appearing on forms where one field had multiple dependency conditions defined. For these specific cases, the system did not automatically calculate the form's SDV status, leading to the form not being marked as verified when all available  fields requiring verifications were already individually verified.

Randomization

  • We have fixed an issue with displayed information in the randomization details modal dialog. Instead of displaying the randomization position of each participant within a randomization group,  the number of the randomization group itself was being presented to the end user.

Participants

  • We have fixed an issue with sorting on the participants' overview. Temporary, during an initial sorting action performed by the end user, the list returned all participants records and not just the ones filtered in a previous step.

Data Entry

  • Resolved an issue where longer labels on grid fields in the new web survey view were being truncated or cut off
  • Resolved an issue where in a sub-set of forms - if a date field was configured to allow partial dates, a 'full date' was selected by a user and a dependency created on the basis of that field - the field would sometimes be cleared or disappear in the UI

Study Structure

  • We have fixed an issue regarding the display of visit and survey form numbers in the 'Edit form' modal.

User Management

  • We have updated the validation of the email field in the 'New user' modal.
  • The New User modal has been updated. If there is only one row listed, clicking the 'X' button will remove the current row and add a new, blank row.
  • We fixed a defect regarding the use of '<' and '>' characters in role names.
  • We have updated the error message that appears when an invalid email address is entered in the New User modal.

Minor release 2023.4.3.0 - Release date 14th December 2023

  • We have fixed a system issue that logged users out of the system when the `/records/get-info` endpoint was being used. 
  • Resolved an issue where archived surveys were being included in the survey listing by default on navigation, cluttering the listing. Users are still able to view archived surveys using the filters on the listing, but they are no longer included by default.
  • We have resolved a defect that prevented calculations from running as expected, when a form was built with a summary field that was referencing the same variable used in the calculation. This issue only occurred when the calculation field was positioned after the summary field. 
  • We have addressed an issue that prevented the display of randomization details for users that have permissions to view randomization, but not to randomize
  • We have fixed a defect that produced an error when using the modern survey views for calculations that used slider fields as a variable 
  • Resolved an issue where surveys without footers were having issues printing

 

Maintenance release 2023.4.4.0 - Release date 18th January 2024

  • The QR code that is used to setup 2FA would sometimes did not appear. We have changed the way we display the QR codes to make sure they are displayed correctly, all the time.
  • A series of minor security issues were addressed and fixed regarding improved API endpoint authorization and accessibility to surveys data when survey access code are enabled.
  • We have fixed an issue related to Survey 'Completed on' dates in the Participant Data Export. The date on which all fields are filled in is now used by default. If not all fields are filled in, the date the survey is finished is used instead.

Maintenance release 2023.4.5.0 - Release date 2nd February 2024

  • We have resolved an issue that could have saturated the queue during a Form Sync merge process, that could have potentially prevented temporarily other studies from performing a similar Form Sync merge process. 

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