Release Notes Version 2.8.1

Release July 2, 2012

The following changes apply to Study Teams:

• Removed: the "Printer Friendly Version" link for the originally approved HUM application. This view was updated each time a Regulatory Management release changed the HUM form (e.g., questions); therefore it did not reflect the original data in the application at the time of approval. The HTML view of the originally approved application remains available and provides a static view of the original application at the time of approval.


• Fixed: In the Data Safety and Monitoring Plan section of the HUM application, question 32-2.3 is required. The system will now validate this requirement upon submission.

The following change applies to Core Staff & Committees:

• Reviews: A new review with the State of "Initial Review" will appear on the IRB tab when a submission (i.e., application, amendment, adverse event, or continuing report) that was previously withdrawn or removed from the agenda is re-executed and the same reviewer is selected as in the original review. The previous review will also display with a State of "Withdrawn."