Version 4.4.5

August 12, 2019

Human Subjects Applications

  • A new application type has been added to manage external participating sites where the University of Michigan is the IRB of record. The ability to create associated Participating Sites is available from a Multi-Site Application's home workspace. Generally, Study teams will create associated Participating Sites after reliance agreements are in place. See the Participating Sites documentation for more information.

For IRB Staff

  • A record has been added to the History tab to indicate when the annual No CR required notification was sent.
  • Question 21-1.3.2 text has been updated to clarify reporting requirements.

For Conflict of Interest Committee

  • The M-Inform system now receives HUMs' IRB Approval Date and Current Expiration Date as part of the nightly feed sent from the eResearch Regulatory Management system.

For Protocol Review Committee

  • A wording change was made to the Mail Out Agenda activity to reduce confusion; it now says "Notes from sender" instead of "Notes from IRB Staff".