With our minor release 3.4.0 we introduced several new features, improvements and bugfixes. See the most important updates below.
New Features & Improvements:
- Source Data Verification (SDV): With this new function, the verification process can be documented in the input form and output in reports. During the study setup, the user can also select which fields are meant to be verified to enable a risk-based monitoring approach.
- Performance improvements: These improvements include faster loading of ePRO forms, saving new data entries in ePRO and eCRF or updating existing ones.
- Self-registration enhancements: The self-registration module has been further adapted to enable successful registration even after re-scanning the QR code. In addition, further security packages, as well as the specific audit trail events for this module have been added.
- Copy protection for ePRO questionnaires: In order to ensure conformity with the requirements of license givers, ePRO users will no longer be able to copy ePRO questionnaires or print them out via browser.
Fixes:
- Audit Trail: Several fixes were made to the audit trail. These include displaying the ePRO open event when ePRO is opened, showing a complete history of field-data changes in the field audit trail, and displaying all IDAT-related events in the audit trail.
- (S)AE: Fixes made for the (S)AE module include that the completion percentage of (S)AE overview is now in synch with subject overview, the changelog includes detailed information for create/update notifications, and (S)AE overview percentage is recalculated after changes in step 3.
- Self-Registration: Fixes related to self-registration include triggering the ePRO after the subject completes self-registration, removing the display of completion percentage for the contact form, and synchronizing selected IDAT fields and IDAT fields in the contact information form.
You can view and download the release notes for the 3.4.0 version update here.