Release Notes (v19.09)
Protocol First Enhanced Functionality Release Notes [Release 19.09]
We have a lot of 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 Protocol First production upgrade released on September 30, 2019.
Update protocol versioning to support field and form additions to started visits/logs
The P1 EDC has been updated to allow for field additions to be applied to visits and logs where data entry has started or is complete.
When a protocol configuration update is identified, an analysis will be done to determine whether the update is applicable for a new protocol version (i.e. a protocol amendment) or if the update should be applied to any previous versions of the protocol. When previous protocol versions are updated, a new icon will be displayed for site users to identify new data entry fields.
Subject Log display added to visit screen
Subject Logs are now available on the Visits screen to allow for CRA Review and Query counts to be easily viewed.
Option to select procedures for unscheduled visits
A pop-up selection box has been added to allow users to select the required procedures for any unscheduled visit. This will prevent incorrect Procedure counts from being noted going forward.
Clinical Listing Report
A new Clinical Listing Report is available to all users that provides consolidated data for the selected procedures and/or logs. All procedures and logs are available to include in the report, with the limitation that up to 10 are allowed to be selected for a single report.
The report is in excel format and is available from the main Site Listing screen. The data within the report is limited to the subjects(s) the user has access to.
Report Dashboard
A new Dashboard Report is available to all users that provides details for all CRA Review Comments and Data Management Queries. A listing of all queries are available as well as a summary of counts at the Site, Subject, Visit, and Procedure level. Query Aging (by site and procedure) are also available. Finally, a list of all deviations/exceptions are presented.
The report is in excel format and is available from the main Site Listing screen. The data within the report is limited to the site(s) the user has access to.
Standard Minimum Year for data entry
A minimum allowed year of 1900 has been enabled for all data entry to avoid data entry errors and unnecessary queries on bad data (e.g. year = 924).
Extended Session
The Extended Session was not functioning as expected for all user types, this issue has been resolved.
Crossed Out Log Entries
The count of CRA Review Comments, and DM Queries was not working as expected for crosses-out log entries. This issue has been resolved and crossed out rows are no longer included in counts or viewable (as a complete log entry).