Release Notes Version 3.8

Released July 12, 2015

The following changes apply to Study Teams:

  • A "Ready To Submit" Column has been added to the Study Team Inbox.
  • MCRU has been added to the selection list for Post Correspondence.

HUM submission changes:

  • Update to application question 13.3.1
  • Question text updated from "Please indicate what information you will be collecting from subjects that will be paid for their participation. " to "Please indicate what information you will be collecting from subjects in order to distribute their incentive or compensation."
  • Application Sections 15 & 16
  • Validation rules, which set conditionally displayed questions, have been updated.
  • Update to application question 19.1
  • Contact information has been updated and note has been updated to “NOTE: If you selected any of the boxes for 19.1, you are required to submit an application to the Human Pluripotent Stem Cell Research Oversight (HPSCRO) Committee. Email HPSCROquestions@umich.edu for an application form and instructions. IRB approval will not be granted until HPSCRO approves the application.”
  • Section 42 has been revised and Section 42-1 has been removed.

Update to Adverse Event/ORIO question 6.4.1.2

  • Question test updated from "Explain how the nature, severity, or frequency of the event(s) or information" to "Explain how the nature, severity, or frequency of the event(s) or information was NOT expected, given descriptions in the study documents or characteristics of the subject population being studied."

The following changes apply to Core Committees:

  • A comments field has been added to the email notification for the Mail Out Agenda activity in the Meeting workspace.
  • The Manage Meeting Documents activity in the Meeting workspace was failing to complete the generation of the IRB Staff Detailed Agenda word document.  This has been fixed.
  • For IRBMED, the template and file type for the SCR finalize documents activity has been updated.  

The following changes apply to MIAP:

  • In the MIAP workspace, the listers updated on the Office and Previously Reviewed Studies to allow filtering and sorting on the MIAP Staff Owner.
  • In the email notification for the activity, For MIAP and Core Committee Only activity, the link to the study did not work.  This has been corrected.
  • Issue with submissions for which MIAP had completed the review failing to display in the Previously Reviewed Studies tab of the MIAP workspace corrected.
  • Conditions that set MAIP review updated to:
    • Drugs – If 15.2.1 (agents not approved by the FDA) has an item listed and 15.2.10 is not a company (including when 15.2.10 is null).
    • Drugs – If 15.2.14 (FDA-approved agents used “off-label”) has an item listed and 15.2.26 is not a company (including when 15.2.26 is null).
    • Devices – If 16.2.1 (devices not approved or not cleared for marketing by the FDA) has an item and 16.2.8 has Significant Risk checked and 16.2.9.4 is not a company (including when 16.2.9.4 is null).
    • Devices – If 16.2.12 (devices being used off-label) and 16.2.24 has Significant Risk checked and 16.2.25.4 is not a company (including when 16.2.25.4 is null).
  • Submissions that trigger MIAP review in the state of PRC Review Complete will now display on the Pre-Submission tab on the MIAP workspace.

Institutional Biosafety Committee (IBC)

A new IBC Application is being piloted by the IBC Committee. Access to this new application is limited. Plans for a full release of the new application will be communicated in the fall.


Repository Application

Updates were made to the Repository Application being piloted by the IRB-MED. Access to this new application is limited. Plans for a full release of the new application will be communicated later this summer.