Release Notes (v20.08)

P1 EDC Enhanced Functionality Release Notes [Release 20.08]

The following features have been added as part of the P1 EDC production release on August 26, 2020.

In addition to enhancements around the integration with Clinical Pipe, there are a lot of exciting updates to the Certified Copy workflow to better support remote monitoring!  Please acknowledge these Release Notes that will serve as training for enhanced system functionality.

Feature Enhancements

Filter for Subject Log Entries

Subject logs can now be searched by keyword terms, dates, CRA Review and DM query status.  The status and keyword filters have been added to all Subject Logs.  

Include Certified Copy Icon on Subject Log Rows

Subject Log rows will now display the photo icon when a certified copy is uploaded to a specific log row

Allow User to Update Associated Deviation

If the incorrect deviation is selected to associate to a not done visit or procedure, or a visit started out-of-window, the user will be able to update the selected deviation or create a new one using the same functionality to modify visit dates.  

Reverse Exception Certification

Site users will have the ability to reverse the certification of an exception from CS, NCS, or PD so that it can be corrected. 

Differentiate Training for Non-EDC Systems

A subset of training articles will be presented to users who are not associated with a full P1 EDC system (i.e. Source Upload/Remote Monitoring only users).

Allow Presence of Clinical Listing to be Configurable

The Clinical Listing Report will only be available for full EDC systems.

Disable Deviation Workflow for Non-EDC Studies

If a study is not configured for full EDC (i.e., Source Upload Only), the visit not done and visit out-of-window workflows will be disabled so that the user does not need to link a log entry when these events occur.

Updates to Certified Copy Workflow

Update ‘Was Procedure Performed’ Question for Non-EDC Studies:  For systems that are utilizing Source Upload only, the initial question on each form will read "Are there relevant certified copies to be uploaded for this visit?" rather than “Was the procedure performed?”

Display Upload Date for Certified Copies:  All certified copies will be uploaded under a subheading that includes the date that they were uploaded.

Certified Copy Audit Trail Features:  Enhancements have been made to provide additional audit trail details on the front end.

Certified Copy Audit Trail:  The audit trail icon will be available to site and CRA users for viewing details on Certified Copy change history.

Restrict User Drop Down for Source Upload:  When uploading source, the user will be restricted to the current user.  (Previous functionality allowed for any user at the site to be selected in a drop down).

Certified Copy Signature Pad Upgrade:  When uploading certified copies, the signature pad will automatically display the current user’s name and allow selection of a signature.

Search Certified Copies:  Uploaded Certified Copies are searchable at the procedure and visit level as well as within Subject Logs.  PDFs and images are scanned for text to allow for searching.  Medical related terms can be searched for conditions, medications, procedures, labs, tests, etc.

Certified Copy Invalidation:  If a procedure or log entry has been submitted for review or marked as review complete, certified copies uploaded to that form will not have the ability to be invalidated.

Allow Invalidation of Complete Document:  When invalidating a certified copy, the user has the option to invalidate the selected page or the entire document.

Remove Ability to Revalidate Certified Copy:  Once a certified Copy has been invalidated, re-validating will not be allowed.

Invalidate Page View:  Invalidated pages will no longer be viewable by the CRA in the thumbnail or full page view.

Include RFC for Invalidation of Certified Copies:  When invalidating a certified copy, the user will be required to enter the reason for the invalidation.

Show Invalidation RFC Information in Signature View:  The Reason for Change will be viewable with the signature view.

Certified Copy View Original Link Visibility:  The “view original” link will only be available if specified in the configuration.

Updates to Dashboard Report

Include “Deviation Logged” at the Procedure Level:  A column to note if a deviation was logged for a procedure (CRF) has been added to the CRF Listing tab in the Dashboard Report.

Include sorting in Report:  Where appropriate, all tabs are now sorted appropriately by site, subject, visit, procedure, log row.

New Tab for Subject Logs:  A new Subject Log tab similar to Visit Listing tab has been added to roll up details from Subject Logs.

Include exceptions:  A new tab has been created that includes flagged exceptions as well as their certification status and any associated events.

Monitor Query Listing: Include Open Username:  A new column will display the username of the monitor that created the CRA Review Comment (query).

Query Listing:  Auto vs manual queries will be distinctly noted

Defect Fixes

Queries in Crossed Out Rows

Subject Log rows will no longer be allowed to be crossed out in the following scenarios:

1. The log row has an open or answered query from Data Management
2. The log row has an open or answered automated query
3. The log row is Submitted for CRA Review
4. The log row has a CRA Review Comment

Error When Measurement Configuration Updated

If a configuration update was made that removed a pre-specified reference range, a client error occurred when loading the visit.  This has been resolved.

Correct Typo on Training Landing Page

There was a misspelling on the Training website landing page that has been corrected.

Correct Exports Failure When Unit of Measure Not Specified

The export functionality was updated to not require a unit to support observations reported in dimensionless quantities (e.g., pH, specific gravity).

Socket Hang Up Error

A user error was previously encountered for a long request.  If an API request takes too long to respond, client will receive an error, which is resolved now by keeping the connection alive.

Escape Apostrophe in Site Name

An apostrophe in a site’s name prevented breadcrumb navigation to the site page using breadcrumbs.  This has been resolved. 

Pre-specified Normal Range with LLN = 0

If a normal range type has the low value set to 0 or 0.0 the system rendered this as if no pre-specified range was displayed.  This has been resolved.  

Measurement Formula When Units Not Applicable

If units were not applicable for a measurement, the formula for the exception did not execute.  This has been resolved.

Clinical Listing Report Not Displaying Linked Log Row Names

The Clinical Listing Report will display the measurements for linked log rows, including the log row name itself.

Fixes to Dashboard Report

CRF Listing Noted Incorrect MFC:  For measurements marked as Not Done, the user interface displayed the accurate MFC (Missing Field Count), however the Dashboard Report was displaying the MFC incorrectly.

Query Listing: Status & Open Date discrepant:  This has been resolved.

Query Listing: Cleared auto queries displaying on report as open/answered:  This has been resolved.

Query Listing: Close User not populating when auto queries are closed:  This has been resolved.