Version 4.3.2

August 18, 2018

This release contains small improvements and resolves issues.

IRB Staff

  • An issue causing IRB staff to not be able to edit specific sections of the HUM/AME has been fixed.
  • Previously, Self-determined Not Regulated or Self-Determined Exempt applications amended and submitted for IRB review could not be moved from the state of "Self-Determined" to an appropriate IRB review determination. These applications will now transition to an appropriate review determination state (e.g., "Approved", "Exempt", or "Not Regulated").
  • For Staff Reviewers, the old criteria for the Exemption #1, #2, and #3 auto-contingencies did not verify whether the study was exempt application type and had the corresponding exemption category selected. These criteria were added to the method for the Exemption #1, Exemption #2, and Exemption #3 specific contingencies.

Human Subjects Application (and/or Amendments, if applicable)

  • In question 6.8, links to Risk Level help have been updated and links to Risk Grid in the application have been removed.
  • Not Regulated Self Determined and Exempt Self Determined had a subway map indicator of red which is used to indicate a terminal state/needing attention. Since both of these states are now amendable the indicator now displays green for this state.
  • An annual reminder email will now be sent to all study teams with applications that have No CR required on the anniversary of the No CR required determination.
  • A new activity, Upload Non-UM IRB Approval Documents, allows UM study team/IRB staff to indicate when an approved ceding application has had the external approval of the UM site granted, with optional document upload. If this activity has not been completed on an approved ceding application, a reminder notice will be sent at 30, 60, and 90 days (only).
  • For more accurate Cancer Center reporting, a new question has been added to Section 1-2: "1-2.5 Is the study related to cancer, cancer risk, or cancer care delivery?" To better relate to current business needs, changes were also made to to section 1-6 PRC Information.
  • Links referring to Michigan Medicine related URLs have been updated in both the application and the help text.
  • An issue preventing Exempt Self-Determination activity from showing in the history has been fixed.
  • Section 11 and 11-2, Confidentiality and Certificate of Confidentiality, have been updated.
  • An issue with conditional display on the "Is CR Required" questions on Record Decision activities for PRC has been fixed.
  • Award Projects can now be linked in HUM and AME Section 2 and in the Sponsor section of the Repository application.
  • On Section 42 Michigan Clinical Research Unit (MCRU) Information, changes requested by MCRU were made. The changes include some additional answer options and renumbered questions.
  • On the Assign for Review activity on HUMs and AMEs, the default MCRU Reviewers were removed.

HUM, AE, AME, and CRs

  • Added the ability to Update CR Required Flag on Record Contingency Review Decision Activities.
  • The following change applies to Continuing Review(CR):
  • An issue causing an error when approving Humanitarian Use Device SCR was corrected.

Repository Application

  • Award Projects can now be linked in HUM and AME Section 2 and in the Sponsor section of the Repository application.

IBC Application

  • IBC contact information was updated on all notifications.