Release Notes Version 2.7

Release April 23, 2012

Study Teams:

To facilitate IRB and BEU (Biomedical Engineering Unit) review for studies utilizing devices, sections 7-2 Special Considerations and 16 Devices in the application have been updated:

Image of exemption 7 description
  • Question 7-2.1 (device use) revised to clarify that non-IRB HSBS applications require completion of section 16.
  • Question 7-2.1.1 (device as object of study) only appears for studies sent to IRB-HSBS for review.
  • Question 16.1 identifies if BEU review needed (for U-M Hospital & Health Center studies only). Sub-questions have been updated to better identify device use.

Other application changes:

  • Question 3-1.3: To identify international research, the Country is now required as part of the site address.
  • Question 32-2.2: New validation added on the selected study oversight/safety monitoring entity based on whether the study will route to PRC (question 1-2.5).
  • Section 42.1: Two MCRU resource options added - Biorepository Controlled storage environment for biological samples and Destination Programs.

Amendment changes:

  • Based on your feedback, the coversheet has been updated for clarity to include more options, which appear in section number order and with updated text and directions.
  • New question (1.3.1) appears for BEU review (applicable to U-M Hospital & Health Center studies only) if "Change to or addition of study devices" is selected in section 1.3. This is similar to question 16.1 in the application.

Activity changes - Study Teams:

  • UMClinical Studies Posting: additional fields required (e.g., location of study), condition list updated, and the Posted End Date field has been renamed Expected Recruitment End Date.
  • Generate Not-Regulated Self-Determination Letter: PIs can now run this activity for Quality Assurance/Quality Improvement - Clinical or Procedures studies.

Activity changes - Core Staff & Committees:

  • A new activity, Send Back for PRC Review, works like the Send Back for Ancillary Review activity.
  • Edit Approval Period activity available in Expired and Expired - Continuation in Progress states.
  • Suspend activity updated to function like Voluntary Hold activity.
  • Voluntary Hold activity renamed Project Hold.
  • Additions and removal of committee members with the Edit Agenda Information activity are now recorded on the parent and all child submissions.
  • When reassigning a submission from one agenda to another, use the Remove from Agenda activity followed by the Full Committee activity. If you omit the removal step, you will receive a system error.
  • For IBC Reviewers: A new IBC Registration activity, Submission Summary, replaces the view printable version of the registration form.


Edit rights have been extended on submissions in specific states. Check with your department to determine the appropriate business processes when editing a submission.

IBC Reviewers:

New - an agenda form specifically for IBC review! This agenda lists registrations by biosafety level and includes details such as registration type and a link to the new summary view.


New Meetings workspace (Agenda tab) functionality - you can now search for and sort Agenda Items, as well as link to the Submission workspace.