Release Notes Version 4.0

Released October 17, 2016

The following changes apply to the Human Subjects Application:

Multi-site Research application type

A new “Multi-site Research” application type is now available within the human subject study application. This application is designed primarily for research projects where U-M is serving in any of the following roles on the project: Data Coordinating Center; Clinical Coordinating Center; or IRB of Record for non-U-M sites. When U-M is also a performance site, a separate application may be required for local site considerations. Study teams should contact the applicable IRB for guidance on using this new application type.

Summary of differences between Multi-site Research Application and Standard Application types:

  • Removed questions that were only U-M performance site specific
  • Provided a spreadsheet to list performance sites and enrollment numbers
  • Provided an alternative means of providing local site context information
  • Provided a spreadsheet to support aggregate reporting of Adverse Events

Note: A spreadsheet listing Multi-site Research Application questions is available on the eResearch Regulatory Management Training page.

An update to the Link Related Projects activity will allow IRB staff to link human subject study applications (HUMs) to related HUMs, Repository applications, or Unfunded Agreements. IRB staff will maintain these links based on submission evidence (including HUM question 1.1.2) and other input from study teams. Once linked, basic information about the related project will display on the HUM’s home workspace in the Related Projects tab. Access to the related project is based on security to that specific item.

Continuing Reviews with an Exempt or Not Regulated Determination will now display a copy of the review submission.

Updated the URL link to the Financial Interests Disclosure Form for Investigators Not Affiliated with the University of Michigan.

The following changes apply to IRB staff:

The Repository Application Manage Documents activity now correctly saves documents to Shared Supporting Documents.

Studies in the state of Project Hold no longer expire three days early.