Major Release 2025.1.0.0 |  Planned Release Date:  March 25th 2025

Please note that these release notes are preliminary and may be subject to updates.

New Features & Enhancements

In our video below, our solutions consultant, Mike Murphy, will walk you through the key enhancements with this update. Below that we also provide additional detail on these key enhancements. So dig in!

Updated Interim Reports for Mid-Study Updates  

In v2025.1.0.0, we are rolling out additional files to the already existing Interim Data Impact Report for mid-study updates using Form Sync.

Interim Data Impact Report for ‘Signature’
Study admins and others with permissions to manage mid-study updates can now preview changes that may require re-signing CRFs. A new "signature_drop_impact" column in the "structural-changes.csv" file provides a high-level indication of potential impacts, while a "signature-impact-per-participant.csv" file offers detailed participant-level insights. This allows for better planning and reduces unexpected re-signing efforts.
Note: The interim report evaluates each change individually and does not predict cascading effects on parent elements (e.g., visits). If multiple changes occur at once, the system will reevaluate and may automatically reapply parent-level signatures after the sync is completed.

Interim Data Impact Report for ‘Lock’
Study users in charge of planning mid-study updates can now preview detailed impacts on locked forms within the Form Sync interim report. A new "Lock_impact" column in the "structural-changes.csv" report provides high-level indicators, while a "lock-impact-per-participant.csv" file offers granular details on affected CRFs. This ensures better planning and minimizes unexpected re-locking efforts.
 Note: The interim report evaluates each change individually and does not account for cascading effects on parent elements (e.g., visits). If multiple changes occur simultaneously, the system will reevaluate and potentially reapply parent-level locks after the sync is completed.

Form Builder

The form editor has been migrated to a modern UI framework  for improved performance and consistency. This transition streamlines the process of duplicating and editing fields in redesigned study forms, making study design faster and more efficient.

Changes towards feature-parity with the legacy interface 

All previously available features, functionalities and capabilities have been kept during this redesign. A highlight of what these are in the Form builder is below. To access the redesigned form building or form editing pages, the user must have the 'FORMS' management permissions granted. Otherwise, the  menu items will not be displayed.

General layout
All three pages will have a standard layout, comprised of:
The top side of the form builder page has a dynamic title based on the selected menu item,  drop-down inputs for selecting one the available forms, a search input and  3-dot menu, where the functionalities for import, export and print have been moved to.
The main area of the form builder page has expandable field cards or field containers, corresponding to each individual field that has been configured as part of the form.
The right side area of the form builder page, has a  component with all available field types that can be configured for the selected form.

Empty Screens
In the redesigned pages for building forms, we have kept the two variations of empty screens as before (shown in correlation to the defined structure in 'Study design' →  'Study structure').

Users can open external resources and quickly navigate to the  Study structure from the empty screen page content.

Search bar / Field Finder
The search-bar will lookup up fields from across all visits, repeating data and survey forms. Specifically:

• Users can search by field type, field label and field variable name. 
• The search mechanism returns results based on 'contains' logic.
• The found results show the field’s type, the field’s variable name and the field’s location.
• If no results are found, the system returns ‘No results found’.

When the user selects one of the returned results, the system will redirect the user to the form where the selected field is located.

Inline editing for field labels & variable names
Study designers and admins can update field labels and variable names directly in the modern Form Builder without opening the full configuration panel. Inline editing supports keyboard navigation, includes real-time validation, and auto-saves changes upon exit. A success message confirms updates, which are instantly reflected across relevant views and logged in the audit trail.

Field creation with Billing  code check

A validation ensures a maximum of 50 fields can be created in a study when a valid billing code is not stored in the Study Settings. Users will receive an error message if they attempt to exceed this limit.

New icons for field actions (add, edit, delete, move, copy)

• Add & Edit: Clicking opens a dedicated dialog.
• Delete: Opens a ‘Delete Field’ modal before confirming deletion. After deletion, dependent fields update automatically.
• Move Field: Users can relocate fields within the same visit, repeating data, or survey. If domain configurations are impacted, users receive a confirmation dialog. All movements are logged in the audit trail.
• Copy Field: A dedicated Copy icon allows users to duplicate fields with options to retain dependencies and domain variable names.
  • "Copy Field" completes the process without redirecting
  • "Copy Field & Edit" redirects users to the new field’s location for immediate editing

All field movements, copies, and edits are logged in the audit trail.

Study Status Banner
When a standalone study is in status "Live", the corresponding banner is now shown. For Production studies linked with Form Sync, a second variation of the banner is displayed. In both cases, only the Export & Print empty CRF actions remain available.

 

Enhancements beyond feature-parity 

Navigation improvements
The form-building interface has transitioned from a menu-submenu structure to a modern, tabbed layout for better usability and consistency with Study Structure pages.
Study Forms & Option Groups are now under the Study Design menu. Tabs for switching between Visits, Repeating Data, and Surveys remain visible while scrolling.
Import Structure, Export Structure, and Print Empty CRF options now appear next to the search bar for a cleaner UI.

New URLs
The Study Structure pages allow more granularity when navigating the specific tabbed views with updated URLs.

Drag-and-Drop field reordering
Building study forms just got easier! You can now reorder fields effortlessly with drag-and-drop, ensuring a smoother workflow and better protocol alignment—no more tedious manual adjustments! Changes are auto-saved, dependencies are maintained, and updates are logged in the audit trail.

Interactive Field Preview
The redesigned form builder now features an interactive field preview, allowing real-time interaction when expanding a field card. Users can verify field configurations without creating test participants, streamlining form building. Additional options, such as slider orientation, are now directly accessible from the preview.
Note: Not all field types support interactive previews yet. Future updates will address static images used for fields that do not collect data (e.g., QR codes, Repeated Measure Grid) as well as template-based fields.

Field categorization & sorting
In the redesigned Form Builder, available field types are grouped based on their purpose and characteristics. Fields within each group are sorted alphabetically (A-Z) to make selection easier.

Encryption visibility
Study designers can now easily identify encrypted fields as a dedicated encryption icon is displayed next to field labels. Hovering over the icon reveals a tooltip: “This field is encrypted.” The indicator updates in real-time when encryption settings change and is fully accessible via keyboard navigation.
 

Calculation Helper Tool 

Study builders can now access Castor’s external Calculation Helper tool directly from the Form Editor when configuring calculation fields. A new "Calculation Helper" button allows quick access in a new tab with the user-inputted calculation template pre-filled, reducing workflow interruptions.

Bulk-update grid configurations

Updating a grid field that shares a domain variable name with other grid fields now prompts you to choose whether to apply the changes to all associated fields or only to the current field. This ensures consistency across visits while providing control over domain variable updates.

Known release limitations Form Builder

The signature drop dialog may not appear when duplicating a field. This issue will be addressed separately in an upcoming release.

Data Entry & Data Validations

Bulk ‘Value Missing’ Action Improvements
When executing a bulk ‘Value Missing’ action (e.g., from the form-level menu), data points that are unavailable due to field dependencies are now automatically skipped. This prevents errors and ensures smooth processing. All available data points update correctly, with no unnecessary warnings displayed.

Real-Time Validation Updates for Partial Date Changes
For studies using the updated validations logic released with v2024.4.0.0, validation messages now re-evaluate asynchronously across all participants when partial date configurations are changed. Existing validation messages are closed, created, or reset based on the updated conditions, ensuring real-time accuracy. All changes are logged in the study’s audit trail for transparency.

Real-Time Participant Progress update after Data Import
Expanding on our v2023.1 update, which introduced background progress recomputation after Form Sync operations, we’re now bringing this efficiency to Data Import in v2025.1.0.0. This means participant progress and dashboard insights stay up to date without manual intervention, across all of the study’s participant records.

Web Surveys (ePro)

Use the site date format for participant-facing elements

An option that makes dates displayed to participants in web surveys use the same date format as their associated site is now available within the study settings screen. This is turned ON for all newly created studies, all existing studies have this set to OFF but can turn it on at their own discretion. This will only apply to studies using 'Modern web surveys' - the surveys UI made available from late-2023 onwards that all newly created studies already have activated by default.

Exports

Unified Exports page 

We have standardized the export download process across CDMS. Similar to Participant Data exports, all exports are now handled asynchronously. Once you request an export, you can monitor its progress on the Exports page and will receive an email notification when it is ready for download. This ensures a consistent experience for all exports. Additionally, we have standardized the naming conventions for ZIP files generated during the export process.

Customizable domain variable / column names for grid and checkbox fields

We have added the option to override the suffix in domain variable names for cells in grid fields and for options in checkbox fields. Previously these were automatically generated by either taking the position of the grid cell (e.g., B4) or the checkbox label cut off at 17 characters (e.g., history_of_smokin). 

The defined variable names are used as column names in export files, and the domain_mapping and variablelist files are updated to include the option names and values.

The variable names can be exported and imported using the Form Structure XML export and import, and can be synced using Form Sync.

As it is now possible to assign custom variable names to grid cells, we changed the maximum length of domain variables for grid fields to 17 characters.

UTC timezone in the Audit Trail Export

We have updated the Audit Trail export to export the triggered_on timestamp in the UTC timezone. This timestamp is also formatted in ISO 8601 format with offset information. Other timestamps in the event_data column still follow server timezones.

System defects fixes

Data Entry & Participant View

• Fixed an issue where the "Reason for Change" (RFC) grace period was incorrectly reset when saving another field. Now, clinicians can edit the same visit or repeating data field within 30 seconds without unnecessary RFC prompts.
• Fixed an issue where participant signatures were not dropped after merging changes through Form Sync, when a new Visit was created in the cloned test study. Now, signatures update correctly when new visits, forms, and fields are added.
• We have fixed an issue where the "Reason for Change" was not logged in the Audit Trail for participant result events ("Participant result" and "Repeating data instance result") when fields were marked as "Value Missing" with a comment and reason provided in the GCP popup. The Audit Trail now correctly captures the "Reason for Change" as expected.
• Fixed an issue in modern data entry views where new lines weren’t displaying properly in 'Summary' fields, ensuring a smoother and more accurate data experience.
• We have fixed a defect that prevented users with the required permissions to directly update a participant's status from the Data Entry view. The issue was reproducible only when the user would refresh the page right after opening a participant.

Audit Trail 

• A defect was fixed where archived studies could still be accessed via the API using GET endpoints, returning a 200 (OK) response. This issue contradicted the expected behavior of returning a 403 (Forbidden) error.
• We have fixed a defect that prevented configured email notifications for the "Form verification dropped due to edit" event to not be received. This occurred only for studies using the "SDV plans" monitoring feature.
• We have fixed a defect related to loading events in the Audit Trail listing.

Form Sync & Study design

• Fixed an issue where form sync would fail when an option group was deleted before updating associated fields. The sync process now ensures deletions happen last, preventing errors and improving stability.
• We have fixed a defect where it was possible to import a Visit from a Form Structure XML with a name that already existed in the study.
• We have fixed a defect where it was possible to import a form to a Visit, Repeating Data, or Survey from a Form Structure XML with domain variables that already existed in that specific Visit, Repeating Data, or Survey.
• We have fixed a defect related to deleting a field with a domain variable attached. Previously, only a Field Removed event was recorded in the Audit Trail. Now both a Field Removed and Domain Variable removed are recorded upon deletion.
• We have fixed a defect where deleting an empty form or visits, repeating data, or surveys containing empty forms could fail if the study included a calculation with an empty clause ({}).
• We have fixed a defect related to exporting the partial form structure of a study, where domain definitions were not included in the export file.
• Fixed an issue preventing Linked Test Study creation via Form Sync when the allow_randomization_tag_in_calc_field setting was enabled. Linked studies now clone correctly, including this hidden setting.

Exports

• We have fixed a defect related to the ordering of checkboxes in the export grouped by domain.
• We have fixed a defect where additional information was not displayed, when requested, when printing a visit.

Queries

• We have fixed a defect related to the exporting of a filtered set of queries where the Participant Status filter was not taken into account.

Web surveys (ePro)

• We fixed an issue with web surveys where in some scenarios the survey would stay considered as 'Completed' even though new fields appeared through dependencies.
• We fixed an issue where making an API call to a deleted survey would lead to an exception being thrown instead of a 404 response.
• We fixed an issue where in some scenarios a survey package would be marked as 'Completed' immediately after creation.

Castor Connect

• We fixed an issue in Castor Connect where in some scenarios a 500 error would be shown instead of a 401 error.

Misc. 

• We have addressed a defect occurring only on the Mozilla Firefox browser, that rendered the layout of some pages to be incorrect on smaller-sized screens like laptops. This issue was hindering the user's visibility on larger tables like the Repeating Data Overview.
• We've fixed a text copy issue on a dialog showing up when attempting to delete a form with randomization strata.
• We have fixed an issue with the endpoint output for study-level file uploads by removing sensitive "key" and "algorithm" fields from the JSON responses. In future iterations, the response format at the participant level and the output at the study level will be unified.
• We have fixed a defect that rendered an error to occur when calculation fields were used in the template of another calculation field, given specific variable names were defined such as "max", that conflicted with PHP function names.
• We have addressed an issue regarding the generated name for the Interim Data Impact Report, when particularly long names would generate an error. Now, in edge cases where the field's name (before or after change) would exceed 1000 characters, it will be truncated to a maximum of 1000 characters.
• We have updated the Study Settings modified Audit Trail event to include information about enabling the automated re-execution of calculations.