Release Notes Version 3.1.1

Released July 15, 2013

The following changes apply to all user groups:

The existing Section 8-1 (MCRU Subject Participation) has been removed and the remining Section 8 questions have been renumbered.

The following changes apply to IRBMED studies only:

An enhancement to the "Requesting Review by a Non-UM IRB" application type was implemented. This is a change for IRBMED studies only.

This IRB application type is for situations when UM will cede IRB oversight to an external IRB. It provides a limited question set needed for IRBMED and includes Ancillary Committee question sets and routing for review, when applicable.

Ancillary Committee workflows for review and routing are unchanged. This enhancement is being implemented to streamline the eResearch process for studies that qualify for external IRB review.

The attached documents include more information about the changes:

Ceding IRBMED Review Process Changes, July 2013

Ceding IRBMED Application Smartform Changes, July 2013

For more information, please contact IRBMED.