Release Notes (2021.04)

P1 EDC and P1 SU Maintenance Release Notes [Release 2021.04]

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 1, 2021.

Feature Enhancements

Allow Procedure Performed Options to be Configurable

Procedures can now be configured to include a Not Required option for the “Was the procedure performed?” question on a procedure-by-procedure basis. If Not Required is selected, the not done workflow is not displayed.

Certified Copy Performance Improvements

Additional optimizations were made to the certified copy upload and post-processing functionality.
When viewing full size images of certified copies, only pages uploaded on the same day will be displayed in order to make load times faster.

User Interface/Experience Improvements

Explanation text was added to provide inline help on screens where the system prompts for reason why a visit or procedure is marked as not done.
Form State and Missing Field Counts will now be displayed as text rather than buttons.
Sorting and pagination options are now saved to preserve last used choices.
Various links will change cursor to hand when hovering.
Subject and Visit Lock icon will now be shown in the breadcrumb navigation.
An alert message has been added on certified copy invalidation when a page cannot be invalidated.
A Help tooltip has been added next to the Certified Copy section label.
Site list column widths have been adjusted to provide more room to display site names.
Add and Download action links have been updated to buttons to ensure uniformity across the application UI.

Administrator Function Enhancements

Enforce Unique Site Numbers

The system will no longer allow multiple sites to be created with the same site number within any one protocol.

Download Site Admin Page

A link was added to the Site List Admin screen to allow a site list to be downloaded as a csv file.

Add Country to Site Admin Page

A column was added to the Site List Admin screen to display the country for each site.

Protocol and Site List Pagination

Pagination and sorting have been added to the Protocol List and Site List Admin screens.

Site column Added to User Access Report

New column titled “Associated Site Ids” has been added to the User Access Report.

Report Enhancements

Dashboard Report Site Filter

A filter has been added to allow a specific selection of sites to be included when generating the Dashboard Report.

Subject Level Query Aging Added to Dashboard Report

A new worksheet titled “Query Aging - Subject” has been added to the Dashboard Report to provide query aging metrics at the subject level.

System Artifact Enhancements

Grid Item Details Added to Guidance Input Template

The Guidance Input Template was updated to include grid row and column fields for visit assessments in the Measurements to Capture section. A new section titled “Fields to Capture” was also added for logs.

API Enhancements

Site and User API Endpoints Updated

Updates were made to the site and user API endpoints to support more robust workflows for adding and updating those resources.

Defect Fixes

Crossed Out Log Entries Excluded From Deviations Tab of Dashboard Report

Crossed out log entries will no longer be included on the “Deviations” worksheet in the Dashboard Report.

PCS Details on Clinical Listings Report Updated

An issue was corrected that was causing measurements that were no longer exceptions to be marked as PCS (Potentially Clinically Significant) in the Clinical Listings Report.

Get Subject Study Event API Endpoint Not Including Visit Date for Unscheduled Visits

The Get Subject Study Event API endpoint was updated to include the visit date for unscheduled visits.

Crossed Out Log Entry Error When Monitor Review is not Configured

An issue was resolved where an error could occur when a log that was not configured for CRA review was crossed out.

SDTM Issue When A Field Is Added By Version Migration

An issue was resolved that, in some scenarios, created a problem with exported data for fields added as part of configuration update to an existing protocol version.

User List Not Updating Correctly For Site Admins When Users Are Removed From A Protocol

When a user with Site Admin access removes a user from a protocol the user will now be removed from the list of site users that are displayed to the Site Administrator. Previously the user’s access was removed from the protocol but was still included in the list displayed to Site Administrators. The removed users were properly not displayed to Build and Protocol Administrators.

Association From Log Not Removed For Not-done Measurement

An issue was fixed where log associations were not removed when multiple measurements on a CRF were switched from Not Done to Done.