Major Release 2024.4.0.0 |  Release Date:  17-18 December 2024

New Features and / or Enhancements

Form Builder

The form builder page can be accessed directly from the Study design page by double-clicking a form's name, as these are presented in the Study Structure tabs. The same functionality is also accessible via the 3-dot menu.

Calculation field, Summary field, Link field, and QR code field templates now automatically update when a field's variable name changes. If a field used in such a template has its variable name modified, the template will now adjust accordingly, preventing broken fields.

We have added a new option in the Copy Form, Copy Repeating Data, and Copy Survey modals. You can now choose whether the variables in the templates of copied Calculation, Summary, Link and QR code fields should reference the new, copied fields (this is now the default setting) or continue to reference the original fields (the previous default behavior).

We have added a restriction on the deletion of fields used in Calculation field, Summary field, Link field, and QR code field templates. To delete a field that is used in such a template, the Summary field, Link field, and QR code field must be updated or removed first.

For fields where a template can be created (calculation, summary), static system variables have been moved from the tooltip to a separated dialog.  Users can access this list by clicking on a new 'eye’ icon added to the calculation template text area. As opposed to before, each static variable name is presented with a short explanation next to it, in a tabular/grid manner. Users can copy (to clipboard) each static variable name by using the 'copy’ icon and continue building their template with more ease.

Automated (re-)execution of Calculations

We have added support for the automated (re-)execution of calculations. This feature ensures that calculations get (re-)executed automatically in the background throughout the data collection process (whenever data are entered or imported) and when there are changes to calculation templates or the study structure.
 

When the ‘Enable automated re-execution of calculations’ feature is enabled calculations will now automatically re-execute in the backend when:

• field values of a field used in a calculation are updated in data entry;
• (a form containing a) calculation field is created, updated, or copied;
• repeating data instances and survey package instances are created, deleted, or archived;
• participants, forms, visits, Repeating Data Instances, or Survey Package Instances are unarchived or unlocked;
• a participant is created;
• data is imported via the CSV importer, FHIR importer, and API

Automated (re-)evaluation and persistence of validations

This release introduces the automated evaluation and persistence of validations (edit-checks) within the CDMS system. Validations are now automatically re-evaluated in the background whenever data changes occur or when study structures are updated. A complete history of these validations is persistently maintained and can be reviewed in the study’s audit trail.

Automated Validations (edit-checks)

The system will now automatically re-evaluate validations after specific triggers (system events), ensuring an up-to-date and accurate validation status:

1.Direct Data Changes (via UI or API):

• If the condition remains met, the validation is retained, and a ‘Validation status updated’ event (status: NEW) is logged under the user who updated the value.
• If the condition is no longer met, the validation is auto-closed, and a ‘Validation status updated’ event (status: AUTO-CLOSED) is logged under the system user.
• If the condition is newly met, the validation is auto-triggered, and a ‘Validation triggered’ event (status: NEW) is logged under the user who updated the value.

2. Validation Configuration Updates:

• If the condition remains met after the configuration change, the validation is retained, and a ‘Validation status updated’ event (status: NEW) is logged under the system user.
• If the condition is no longer met, the validation is auto-closed, and a ‘Validation status updated’ event (status: AUTO-CLOSED) is logged under the system user.
• If the condition is newly met, the validation is auto-triggered, and a ‘Validation triggered’ event (status: NEW) is logged under the system user.

3.After merging changes via Form Sync (Mid-Study Updates)::

• If the condition remains met, a ‘Validation status updated’ event (status: NEW) is logged under the system user.
• If the condition is no longer met, the validation is auto-closed, and the event is logged under the user who performed the merge.
• If the condition is newly met, a ‘Validation triggered’ event (status: NEW) is logged under the system user.

4. Structure Import 

When field validations are imported through the Structure Importer, a ‘Validation created’ event is logged for each new validation added. These events are logged under the user who performed the import.

Audit Trail Events

We are introducing a new audit trial event  labeled 'Validation removed'. This is used to keep track of any removal of an existing field’s validation configuration. 
NOte: This new event will be available to all studies by default and presented in the study's audit trail page.

To improve tracking of field validation changes, the following events are relevant:

• Validation Created: Logged whenever a new field validation configuration is added.
• Validation Replaced: Logged whenever an existing field validation configuration is modified.
• Validation Removed: Logged whenever a field validation configuration is deleted.

Limitations:

• Validation messages of type ‘Error’ are not included, as these prevent values from being stored in the database
• The Data Import event does not trigger the batch recalculation of Validations
• Hard deleting fields will also hard delete any triggered validations associated within that field
• Enabling this feature on a study predating v2024.4.0.0 will only retrigger and persist validations from the moment it is activated onward

Interim Data Impact Report for Mid-Study Updates

A new feature has been added to enhance the Form Sync process in CDMS. Users can now generate an interim data impact report during the Form Sync process, providing detailed insights into structural changes, data loss, and SDV (source data verification) impacts. Additional enhancements have been made to the ‘Data Impact’ page to improve visibility into cumulative data loss across all study instances.

A ‘Generate Interim Report’ button is now available on the initial Form Sync page for production studies.
 

This allows users to request a preliminary report detailing the impact of changes applied in the test study before merging them into production.

• The report is generated asynchronously, enabling users to continue working within CDMS or review subsequent Form Sync pages while waiting.
• An email notification will be sent when the report is ready for download.
• If no structural changes are found, a toast notification informs the user, and the report generation is canceled.
• The first iteration of this data impact report is in .csv format and contains 4 files: 
  • structural-changes.csv: Overview of all detected structural changes.
  • collected-data-impact-summary.csv: Summary of the impact on collected data, highlighting potential data loss.
  • collected-data-impact-per-participant.csv: Participant-specific view of the impact on collected data.
  • sdv-impact-per-participant.csv: Participant-specific view of the impact on SDV at the field level.
     

Audit Trail Events

The following audit trail events are logged for the interim report:

• Export Requested: When a user requests the report.
• Export Completed: When the report is ready for download.
• Export Failed: If the report generation fails.
• Export Downloaded: When the user downloads the report.
• Export Expired: When the report is no longer available for download.

Current limitations 

• The report provides preliminary insights into structural changes, data loss, and SDV impacts. Additional information (e.g., signature, lock, verification status) will be included in future updates.
• SDV data is included only for studies with active SDV plans and when the ‘Monitoring’ and ‘SDV Plan’ feature flags are enabled.
• The report focuses on field-level SDV impacts and does not account for cascading effects at the form or visit level.
• Data availability due to field dependencies (e.g., when ‘Clear Inapplicable Child Fields’ is disabled) is not factored into the report or preview. Automation engine rules affecting data availability are accounted for.
• Form Sync Interface
  • The ‘Data Impact’ page in the Form Sync process has been enhanced and it now displays cumulative data loss numbers across all instances when fields or option group selections are removed from repeating forms or surveys.
• Cumulative data loss calculations exclude:
  • Data points from forms unavailable due to automation engine rules.
  • Data points in archived instances or participants.

Data Entry Enhancements

This update introduces several design improvements and workflow enhancements to make data entry views more accessible and user-friendly. Changes include better-defined navigation elements, clearer visual indicators, and streamlined workflows for creating and managing repeating data instances in both the legacy and modern data entry interfaces.

The CRF navigation panel has been updated with the following improvements:

• Parent elements (e.g., visits, repeating data instances) and child elements (e.g., forms) are now separated by gray lines for clearer hierarchy.
• The label color of the selected form is now displayed in blue for better visibility.
• Icon positions have been adjusted for a more intuitive layout. 
• Icons are displayed at the form level to represent the data collection status: Not Started; In Progress; Completed

Legacy Interface improvements for Repeating Data Instances

• The navigation possible after creating a repeating data instance has been updated to allow
  • Go Back button: Returns users one step back to the previous page.
  • Go to Parent button: For instances with a defined parent, this button allows users to navigate directly to the parent.
    

Modern Interface improvements for Repeating Data Instances

• Previously limited to the legacy interface, the “Add Another” option is now available across all workflows in the modern interface. This includes scenarios where the first instance is created from various locations (e.g., the overview page, visit menu, etc.)
• Users can now directly create additional repeating data instances using the new ’+’ icon.
• New instances retain the same configuration (type and parent) as the original instance.
• If renaming is allowed, a corresponding dialog is presented during the creation process.
• Users can return to the overview of participant-level repeating data instances at any time. This option is shown as a back arrow with or without accompanying text, depending on the presence of secondary navigation options.
• For repeating data instances with a defined parent, a ‘Go to Parent’ option is always available.
  

Miscellaneous Updates and Improvements  

• The Option Groups management page has been fully migrated to the modern interface framework, aligning its design and functionality with other redesigned pages in CDMS.
  
• The query edit dialog has been updated for consistency across all pages where queries can be reviewed and edited.
• Query actions unavailable to the logged-in user due to insufficient permissions are no longer displayed in the interface.
• The dialog for keyboard shortcuts has been revamped:
• Standard Shortcuts: Common navigation shortcuts (e.g., navigating main and sub-tabs in CDMS) are now embedded into the interface, requiring no additional custom keys. These shortcuts align with WCAG guidelines and include TAB, Shift + TAB, Enter, and ESC.
• Custom Shortcuts: Study-specific shortcuts are presented in a modal dialog and display the correct key name for the user (e.g., Alt vs. Option based on the device).
  
• A new study setting allows administrators to enforce password expiry. When enabled from the ‘Study Properties’ section, users are required to update their password upon login if it has been 6 months or longer since their last password change. By default, this new setting will be disabled for all existing and new studies.
• Public API Enhancement: The POST /study/{study_id}/user endpoint now supports an optional send_invite_email parameter:
  • Default: true (invite email is sent).
  • When set to false, no invitation email is sent to the added user.

System defects fixes

Study Structure

• We have fixed a defect where in specific cases, it was not possible to import calculation fields through the Form Structure import.

Data Entry Views

• We fixed an issue where the language dropdown on a web survey would not be fully visible when using a 320*256 viewport.
• We've fixed a defect occurring in data entry. Fields were temporarily marked as completed, after a value change was canceled on a signed form.
• We have fixed an issue occurring on the modern data entry interface, where data collection would have appeared to be blocked in a specific scenario: If multiple exclusion messages were configured and triggered simultaneously on a single calculation field, the 'Clear source value' was not shown anymore. 

Survey Packages / Audit Trail

• For a small number of studies, the timezone of two metadata points (survey opened & survey started) related to Survey Packages were reformatted from UTC to the timezone of the server for consistency to match other metadata on the server.

  Verifications

• We have addressed an issue that prevented the expected error message to be shown on the 'Pending SDV' page, when study level changes made the previously applied filters on the page to no longer be possible.

 Hotfix Release 2024.4.0.1 |  Release Date:  20 December 2024

System defects fixes

• We fixed an issue where the user would be prompted to login when searching through a large list of options in an option group.