1.5.1 Update Release Notes

December 8, 2006

PI and Study Team

• 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.