Major release 2023.3.0.0 - Release date 22nd August 2023

New features and / or enhancements

Study structure

The design of the Study Structure page has been updated:
Visits, repeating data, surveys, and survey packages are now displayed in a tree view, allowing users to see the entire structure at a glance.
When a study uses Form Sync or the study is set to live, the page now displays an uneditable preview of the study structure. It is, however, still possible to assign user roles to visits, repeating data, and forms.
We have updated the design of the Add and Edit Survey Package modal.
We have added the ability to change survey package notifications after invitations have been sent out. Changes made to notifications will be applied to new survey package invitations created after these changes are made.

Forms

We have added a new {participantStatus} variable to the calculation field, which exposes the participant's status. This enables you to perform certain actions or calculations based on the status of the participant at the time of calculation.
We have updated the design of the Delete Option Group modal

User management

We have added a 'role' parameter to the study-user PUT endpoint. This parameter allows you to update the assigned. role for a user for a specific site.
In the 2023.4.0.0 release, we are introducing a significant change to user management. We have added a banner to the Users tab describing the changes and linking to an overview of the changes that will be made to the study.

SSO

In SSO/SAML requests, we now support passing a RelayState. You can specify a URL to which the user should be forwarded after using SSO to log in by using the RelayState parameter.

Import / Export

We have added support for exporting data for a selection of visits, repeating data and surveys. You can now make a selection of elements in the Export Data modal and only retrieve the data, queries, comments, and verifications for these elements.
We have updated the Study variable list in the Export to use the same numbering as is used in the Data Entry user interface.
We have added the functionality to export the sites added to your study in a CSV file, alongside with their abbreviation, country code, site code, and date format.
We have updated the site import function to use 2-letter ISO 3166 country codes for assigning a country to a site, instead of internal (numeric) codes.
As announced in the 2023.2.0.0 release notes, we have removed randomization fields from the data export. These fields are not exported in the CSV, Excel, SPSS, and export files. In addition, these fields are no longer included in the variable_list files included with the export.

Audit trail

We have updated the "Permissions - User access updated" Audit Trail event to now include user role information upon changing a user's role for a specific site.

API

The parent type and ID of a survey package are now retrievable on the public API
Some unused endpoints were removed from the participant scope (Castor Connect)

Surveys & Castor Connect

We have updated the survey overview screen to make the UI (headers, filters) more consistent with other overviews on the platform
The applicable timezone will be displayed when sending mobile survey packages to improve user experience
Activation management warning text for clinicians has been updated to be clearer
Previous errors and warning messages are now shown using toast notifications. Additional ones have been included and some copies have been updated for the available bulk actions in the global survey invitations listing.

Study settings

The entire study settings page has been redesigned. All previous sections have been moved to tabs to improve navigation. A highlight of the most relevant changes can be found in this section, as some of the features or their behavior has been updated for a better user experience in the CDMS platform, with less redundant steps to reach the goal of your task or workflow.

For simplified navigation, all previous sections have been moved into separated tabs, as presented below:

General tab

We've redesigned the ‘Manage sites’ functionality within the study's settings. Users can now open a new page and easily navigate back to the main settings view, thus having more space to properly oversee, add, edit multiple sites.
When setting a study to ‘Live' for the first time, a 'Go live’ wizard will be presented. This will guide the end user through a set of predefined steps, presenting all inputs required in order to continue. The user can update prefilled inputs during this process or otherwise fill in the missing ones. Navigating forth to the next step in the wizard is permitted only after all required details are correctly filled. Where applicable, the randomization of all participants can be reset in the wizard. If the user chooses to reset, the randomization blocks will be cleared and the randomization will be removed from participants.

Study properties tab

We have redesigned the Study properties and price section of the study settings. All previous inputs and buttons have been moved into a separated tab.

Billing information tab

The previously known 'Invoice details' section has been renamed to Billing information across all studies.
For any running study that has been set live or is live without a billing code, all inputs corresponding to the option ‘without billing code’ will keep on being shown. For any new study as well as existing studies that have not been set to live yet, using the Billing code to proceed is the only option.
A valid billing code is required to set your study live. If the logged in user does not have one, an informative text will guide the user to contract the relevant organization or department.

Good clinical practice tab

The 'Good clinical practice' section of the settings has been migrated and moved as a standalone tab in the new settings page. All functionalities are in place, some copies of the informative texts have been updated for more clarity.

Other tab

The previously available 'Other' section of the Study settings page has been fully moved to a dedicated tab in the newly designed interface. Some of the options here are not presented as check boxes, instead of drop-downs.
Users can manage up to 5 custom columns for the Participants overview and up to 5 for the Repeating data instances listing by clicking on the corresponding buttons 'Manage custom columns - Participants' and 'Manage custom columns - Repeating data' , found in the 'Other' tab of the settings page.
The study setting option to enable IP allowlisting has been redesigned. Study admins can use this to limit the access to a study to specific IP address(s).
Users can create and edit custom patterns for ID generation study by selecting the 'Custom definition' option in the 'Other' tab of the settings page. Available elements can be added from the first columns. The elements that are not available or not compatible are grayed out and cannot be selected. An informative text is shown to the user as soon as the pattern's length is outside of the required limits and the 'Save and use' and 'Preview' buttons will be presented as disabled.
Clicking on 'Save and use' will return the user to the Other tab and the custom pattern will be saved. the Custom definition option in the Generate record IDs with dropdown will be shown as selected
We are limiting the possibility to change the Field encryption feature. As long as you have at least one field using encryption in your study, you cannot disable this from the study settings. An informative message is shown as a tooltip when hovering over the option in the corresponding study settings page.
Users of the study settings page can proceed to configure and manage the signature statement in a redesigned modal dialog. No functionality has been changed here, only some copies of text were updated.

Saving the settings

The save button on the settings page works for each individual tab. If the user has applied changes to any tab without saving and moves to another tab, they will be prompted about unsaved changes. The tab with unsaved changes will stay highlighted for the user.
Any settings changes that are done within modal dialogs are saved on the fly, the highlighting of unsaved changes applied to inputs can be be modified directly on the page

Overview of repeating data instances

We have reworked some of the available filter criteria in the study-level repeating data instances overview for better usability. The previous 'Repeating data' filter was renamed to 'Repeating data name', indicating the exact corresponding column of the table, while the previous 'Visit' filter was moved under a filter labeled 'Parent', as from now on it will be allowed to filter by the visit, as well as the repeating data instance parent.
When the Repeating data is chosen as a parent, a secondary dropdown is populated with a list of all instances that are being used as a parent for another repeating data instance that is available. This list is searchable, so users can quickly find a specific repeating data instance by name.
We have updated the logic of checking user role blinding rules.If a parent is hidden for the user's role, this will now be shown as 'Hidden' on the Parent column.
Additionally, the options in the 'Parent' filter dropdown on the global repeating data listing are filtered out accordingly. This means that visits that are hidden for the user's role across all sites and repeating data instances that are hidden for the user's role on the site where the instance was created will not be available for selection.

Miscellaneous

We have updated the copy of the 'Accept & apply change' dialog in the Form Sync workflow to reflect the update in the underlying logic. Now, following a successful structural update using Form Sync, the data collection progress will be recalculated and consolidated automatically and asynchronously across all of the study's participants. At the end of this processing happening in the background, the progress bar on the participants overview will be up to date.
We have added the ability to drag the 'Option Group Modal'. You can now move the modal across your screen to see the items listed beneath it.
We have updated the rendering of partial dates in the repeated measure field. Partial dates in these fields are now formatted using the date formatting preferences set in the Study Settings.
We have updated the error message that appears when attempting to import a non-supported Form Structure import file format.
We have updated the content of the automatic emails sent out when a new study is created and when an existing one is set live for the first time.
We have extended the option to clear all table selection to the global queries data listing.
As soon as a participant is archived, its corresponding row in the table gets grayed out. This is an extension of the change recently introduced for the global Repeating data listings.

System defects fixes

We fixed a defect in which a form could be created with the exact same name by copying a form.
We fixed a defect in which the maximum number of failed login attempts was not reset after a user successfully logged in with 2FA.
We fixed a defect related to SSO users that were unable to log in due to a locked account status.
We fixed a defect in which importing a repeating form could sometimes result in an import into the incorrect position.
We fixed a defect related to validations for date fields. After saving these fields, the comparison date would sometimes move back one day.
We fixed a defect that caused 'validation replaced' events to be logged in the Audit Trail even when they did not change.
We have fixed a defect regarding the exported date for the time of source data verification, when the data export was used.
We have fixed an issue where an error was returned when a participant status was being updated by the user by changing the label's text capitalization.
We have fixed a minor issue that caused on the created/updated audit trail events to show the deprecated term 'steps' in the event details. This has been fixed, the correct term 'form' is being used.
Resolved an issue where, when a user updated the contents of an SPI through the Resend function - the edits were applied but the display was not updated, giving users the impression their edits were not being saved.
Resolved an issue where, when web survey access codes are turned on for a study that is also using open survey links, users attempting to navigate to those survey links were generating new records but were unable to access the survey.
We have fixed an issue, where the ‘Delete’ button on SDV plans did not get disabled right away after being actioned, leading to multiple delete requests being possible for the end user, which led to an error being displayed.
We resolve a defect where multiple 2FA code submissions were allowed, even after the limit as login attempts was passed and the user was no longer allowed to access the system. Now, the user is locked after 10 attempts to inputs incorrect 2FA codes.
We have addressed a performance issue, where opening a participant in data entry was slowed down on more complex studies what a large number of repeating data instances.

Hotfix release 2023.3.0.1 - Release date 30th August 2023

We have resolved a problem that prevented automation that used condition based on the participant's site for being triggered.
We have fixed a defect related to the maximum length of notifications for web surveys.
We have fixed a defect in the 'Preview of changes in roles and role assignments' page, which prevented the page from loading if a user was assigned a role but had no assigned permissions.
We have resolved an issue where survey package automations were failing for survey packages that had a parent set.
To reflect the new SSO endpoint URL structure, we have updated the consumer URL parameter passed to Identity Providers during SSO login.

Hotfix release 2023.3.0.2 - Release date 1st September 2023

We have resolved an issue where changes made when editing a survey package invitation were not being saved.
We have fixed a defect related to the maximum length of the email subject for web surveys reminders.

Maintenance release 2023.3.1.0 - Release date 11th September 2023

We have updated the role assignment preview page. Users who do not have any permissions for a site (due to being removed during the course of the study) are now ignored in the role generation.
We have resolved a study settings issue that prevented updating the date format of the default 'Test Site'.
We have resolved an issue where survey package instance results for instances without a planned send date/scheduled send date provided by the API were not returned consistently due to them being sorted by availability rather than creation.
We have resolved an issue where options were truncating for radio fields.
We have resolved an issue where, when calculations or summary fields relied on variables in previously submitted repeating data, the first/oldest instance of that data was being used, rather than the latest.

Maintenance release 2023.3.2.0 - Release date 21st September 2023

We have fixed an issue in the ‘Go Live’ wizard that did not present a free text input as expected, but as an empty dropdown instead.
Added survey_package_instance_id to the public API for surveys, giving better filtering/sorting options to users.
We have resolved an issue where the UI for editing expiry notifications for mobile survey packages was behaving inconsistently with other notifications (availability, reminders.) Expiry notifications are now editable in the same way as the others, with changes permitted for survey package instances sent after the edit, but already sent or scheduled survey package instances left as they were before.

Hotfix release 2023.3.2.1 - Release date 29th September 2023

We have updated the summary field to reflect data from the latest update across all Repeating Data instances - extending work completed as part of minor release 2023.3.1.0

Hotfix release 2023.3.2.2 - Release date 11th October 2023

Resolved an issue where participants on archived studies could still receive notifications associated with surveys