Release Notes Version 3.7

Released April 20, 2015

The following changes apply to Study Teams:

The informed consent questions located in section 11-4 Retention of Data and/or Specimen Detail were moved to section 10-1 Informed Consent. A new trigger question was added to conditionally display the questions if future research use is planned.

New Question

  • 10-1.6: At the conclusion of this study, will specimens and/or data be retained for future research use?

Renumbered Questions

  • 10-1.7 (previously 11-4.4): Does the informed consent document explicitly notify subjects that their data and/or specimens will be stored for future research? 
  • 10-1.8 (previously 11-4.5): Are subjects required to agree to retention of their data and/or specimens as a condition of participating in the research?
  • 10-1.8.1 (previously 11-4.5.1): Provide a justification for this requirement. If the information is included in the attached protocol, please indicate section.

The MICHR IND/IDE Investigator Assistance Program (MIAP) now has the ability to review studies so they may assist and support investigators utilizing an investigational new drug or medical device.

IRBMED Studies Only:In order to improve informed consent version control, a Word document version of the informed consent containing an editable instructional cover page will now be created each time the IRB has finalized a consent document. This version of the consent document will be located in the Informed Consent section of the approved application.

The Update NCT Number activity is now available on all studies submitted to IRBMED, including those with an amendment in progress.

For exempt studies, an error incorrectly bypassing section 44 has been corrected.

Application question 21.4 is now only required if questions 21.1 or 21.2 are answered Yes.

An error allowing study team members to complete the Accept Role activity without answering question D1 has been fixed.

An incorrect error message displaying for Not Regulated studies stating that study team members with a Friends account must answer the financial interests questions has been fixed.


The following changes apply to Core Committees:

A Continuing Review process and an Incident Report process has been added to the new Repository Application being piloted by the IRBs. Access to this new application is limited.

The default start time for new meetings has been updated from 8AM to 9AM.

A new Link Related Projects activity is available for IRB Staff in the application workspace.  This activity is used to link a study with a related Repository Application and is available anytime an amendment is not being actively processed.

IRB Staff can now assign issues to MIAP for review using the Edit All Issues activity. Note that this option is not available using the Edit Open Issues activity.

If a study has been indicated for an institutional conflict of interest, there will be a red indicator in the main study workspace.

An error causing the Date Completed to be incorrectly overwritten when clicking Save on the Staff Review Checklist has been fixed.

The method used to assure study team members are not assigned as reviewers has been updated to evaluate both the currently approved and amended member sets.

An error causing the Scheduled Continuing Review (SCR) Printer Friendly Version to display incorrect information for PAF detail in section 2 has been fixed.

An error sometimes causing incorrect information to display for Risk Level History in section 2 of the Scheduled Continuing Review (SCR) Approved Summary has been fixed.