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