Users who select "viable neonates" in Section 9-1 "Subject Populations" are now routed to complete section 33-1 "Children (Minors under the age of 18) - Secondary Analysis-Only Studies".
Identified Issues are no longer truncated under the Correspondence tab and All Issues tab in the Review workspace. Also, links to the application form from these tabs are now working.
Section 3-4 of the SCR form now contains a link to the snapshot of the AE Summary Report.
Notifications & Letters
Email notifications to committee reviewers were being sent only to the staff person who completed the Full Committee and/or Expedite activity. This problem has been corrected so that committee reviewers are now notified when they are assigned a review.
The Approved with Contingencies letter now only lists issues that are marked as published, but not completed.
The Full Committee Approval letter for Amendments now includes a signature.
The Contingencies Pending for the Application and Amendment Approval letter now displays the Core Committee instead of the Core Committee Board.
Core Committee Staff
Outstanding Issues now only display in the states "Changes Requested" and "Contingencies Pending".
Secondary Staff Owners can now see Reviews in the In Progress and Completed tabs of the Core Committee Staff Home Workspace.
The Unassigned tab in the Core Committee Staff user's Home workspace now shows only their committee's unassigned reviews instead of all unassigned reviews.
The list of identified issues in the Edit Identified Issues activity now sorts by section, then by the description text. Additionally, a Date Created column has been added so that staff can easily identify when the issue was created.
Reviews in the Finalized state are no longer editable.
If core staff gives a recommendation of No Review Required or Approve Administratively, the activities needed to process the decision are now available.
Contingencies completed prior to the upgrade were not marked as completed. This problem has been corrected.
Unassigned Behavioral Science and Health submissions are now sorted by IRB, as they were in previous releases.
For Applications and Amendments, the staff note created on the state transition from Validate Committee Decision to Core Committee Staff Review is now being generated correctly.
The Record Contingency Review Decision activity is no longer setting the Approval Date to the activity's execution date.
For Continuing Reviews, the exemption category is now populating correctly on both the Record Committee Decision activity form and the Exempt determination letter.
The Edit Approval Period activity is now available in the Approved state.
Record Contingency Review Decision activity now appears on the History tab in the Core Committee Review workspace.
During Full Committee or Expedited Review, when a committee reviewer requests change or clarification, the secondary owner was not being notified of the request. If the submission has a secondary owner, that person will also be notified.