Release Notes ShareCRF 2025.02

Summary

This is a major release which includes new features, improvements and bug fixes:

New features

• Required-field progress visualization updated. When scheduled visits are enabled, required fields can now be in three pending states: Pending: Overdue (red), Pending: Planned (grey), and Pending: In Progress (orange), each with a distinct color. Progress bars, both within the patients list and the patient, and field status icons have been updated accordingly. For studies without scheduled visits, the color for incomplete fields changes from red to orange.
• New “Pending data” report added. It provides field completion information that can be exported in an Excel sheet, and can be grouped by site or country.
• Patient completion metadata is now always included in exports (previously only included when patient completion was enabled for display), with additional fields added.
  
  • For studies with scheduled visits, exports now include: 
    
    • Number and percentage of required fields that are in the status ‘Pending: overdue’.
    • Number and percentage of required fields that are in the status ‘Pending: in progress’.
    • Number and percentage of required fields that are in the status ‘Pending: planned’.
  • For studies without scheduled visits, exports include: 
    
    • Number and percentage of required fields that are in the status ‘Pending’.
• New date formats are available in the eCRF application: YYYY/MM/DD and YYYY-MM-DD 

Improvements

• Patient list improvements:
  
  • Patient list state (sorting, filters, and page number) is now preserved within a user’s session for the same study and environment. When returning to the patient list, the last state remains applied. 
  • New “Progress” filter added to filter patients by completion state (No data completed, Some data completed, Some data pending: in progress, Some data pending: overdue, Some data pending: planned, All data completed).
  • New “SDV Progress” filter added to filter patients by SDV status (No data verified, Some data verified, Some data pending verification, All data verified).
  • Patient list Excel export now includes additional columns for patient completion and SDV progress.
  • Improved navigation: you can now enter a page number to jump directly to that page. 
• Missing data improvements:
  
  • Missing data details are now available in a dedicated “Missing data” tab within each patient.
  • Missing data can now be applied to non-required fields as well (for empty, non-disabled fields).
  • Missing data counts are now shown split by required, non-required, and hidden fields (in the patient and in the patient list).
  • The missing data report now includes a filter to show missing data for required fields only or all fields.
• SDV improvements: 
  
  • SDV can no longer be applied to empty fields. Empty fields may be included in a strategy, but can only be verified once completed.
  • Previously, disabled fields could never have SDV applied. Now if a disabled field is completed (not empty), and included in a specific SDV strategy, this field will form part of the SDV strategy, and be available to have SDV applied. 
• Exports that include data the user does not have permission to access now fail and return an error (instead of completing with restricted data excluded). An email notification is always sent for failed exports.
• When loading an export template that includes options outside your permissions (e.g., Audit Trail), the template list displays a warning. Loading the template applies only the options you have access to. 
• Publications in the production environment now always run with the Data Integrity enabled, as this option will always be selected.
• Multi-selection rule comparators updated:
  
  • Multi-selection fields can now be compared to other multi-selection fields using the same answer set.  
  • When comparing a multi-selection field to fixed values, you can now select multiple answer options (e.g., “is equal to Value A and Value C”).

Bug fixes

• Fix horizontal display of VAS from the ePRO application, when the VAS slider is configured to include markers on the scale. 
• From the export section, the option to download the audit of deleted patients is only available to users with the access scope ‘All’. 
• Fix so that patients' SDV statistics update correctly when deleting repetition list items, updating the revisable field count correctly. 
• Special character encoding when uploading medical coding dictionaries is fixed to be handled correctly, so dictionaries such as Spanish MedDRA can be uploaded without problems.  
• Fix the display of line breaks shown in a text area field in the query sections of a certified copy. 
• The sessions renewal pop-up (“I’m here”) from the ePRO app is fixed so that no matter where you scroll on the ePRO form, it is shown at the top of your screen. 
• Fix the comparison logic when multiple choice fields use the equal or different to comparators. This was previously not working, and is corrected. 
• From the blank PDF, when a grid was spanning multiple pages, this was causing problems with the page breaks. This is corrected.  
• When a field that is used for stratification of randomization of a patient is marked as missing, randomization of that patient will not be allowed. 
• When an eCRF was configured with an ePRO form that had rules with conditions pointing to deactivated fields outside of that ePRO form, this was causing an error trying to publish this version. This is corrected.
• Fix the display of the name of a person who published an eCRF version from the Control Panel, eCRF Design, Environments section.
• Fix validation reference from the editor from patient statuses. Now when a field being used in the condition of patient statuses is attempted to be deleted, a validation error will be returned for the user, and the eCRF cannot be published. 
• Fix the response of the control panel when creating a folder from the control panel documents section, to fix the false error being shown previously. 
• Previously, child fields that were disabled by a rule would have their background changed to yellow when the form could not be editable (by locking the form, or users permissions). This is fixed so disabled fields always show with a grey background. 
• Fix the download of the global queries list when there are queries that are created on non-empty DICOM fields. This would previously return an error, and now concludes. 
• Correct the maximum time in the future that a scheduled export can be programmed, to 179 days.  
• Previously, utilizing the ePRO status filter from the patients list returned an error. This is corrected. 
• Update to the timezone library to correctly reflect timezone changes in areas that have recently changed their timezones. 
• Fix missing data selector in grids so that missing data cannot be applied to fields that your user does not have view or edit permissions for, as it is not provided as an option in the selector.  
• Fix the application of grid-level permissions. If a grid has access denied to a certain profile, ensure all fields within this grid are not accessible for that profile.