Release Notes (v20.04)
P1 EDC Enhanced Functionality Release Notes [Release 20.04]
We have a few exciting product updates this month, we've rounded them all up here, so you can stay in the know! The following features have been added as part of the P1 EDC production release on April 6, 2020.
Allow User to Reverse Visit, Procedure, and Measurement Not Performed Selection
Site Users will have the ability to update a “Not Done” or “Not Performed” selection for any visit, procedure, or measurement. When applicable, Deviation associations will be removed when reversing the Not Done selection. Previously these updates required approved Change Request Forms and backend data updates by Protocol First.
To modify the “Was the procedure performed?” response for a Procedure or Measurement from “Not Performed” to “Performed”, the response can simply be updated.
Updates to this selection are available in the audit trail associated with the action.
Allow Actual Visit Date to be Updated by User
Visit Dates will be updatable by the user after they have been started. Previously these updates required approved Change Request Forms and backend data updates by Protocol First.
To modify the visit date, select the pencil icon next to the visit:
A screen will be presented to allow a new visit date to be entered. Updates to this selection are available in the Visit Update History audit trail.
Any updates to a visit date do not impact future visit windows, however the Anchor Date can be modified to update future visit windows.
Ability to Lock Subject Log Rows
Data Management will have the ability to lock Subject Log rows, similar to the current Visit lock functionality.
Exception workflow: Include unit for baseline
The unit will be included for baseline measurements in all new exceptions.
Clinical Pipe Integration
Updates have been made to support data entry via Clinical Pipe. This will include a new icon indicating that the field can be populated via Clinical Pipe.
Dashboard Report Discrepancies
The following discrepancies have been addressed in an update to the Dashboard Report:
- CRF Listing: The Submit and Review date were not populating for all Subject Log rows.
- Deviations: A new column (Deviation Associations) has been added to detail the exception associations.
- CRF Listing: A new column (Procedure Performed) has been added that displays Yes, No, or null (if selection has not yet been made).
Certified Copy Add Button Hidden
On the initial unlock of a procedure by the user, the add certified copy button was hidden. This has been resolved.
Subject Log Submission Error
Subject Logs could not be submitted after uploading a certified copy until the log was closed and then re-opened. The issue with this workflow has been resolved and Subject Logs can be submitted for review immediately after uploading a certified copy.