Regulatory Management

Overview The Repository Application is used to track data and bio-specimens associated with human subject research. New repository applications are created and submitted to the appropriate review committee(s). A new repository application may be started and saved for completion at a later time. Important Information Anyone in eResearch can create and complete a Repository Application; however, only the Repository Director can Submit a Repository Application.

Overview Once a Repository Application has been approved, an Amendment must be created to document changes to the application (e.g., changes to repository personnel, sponsors, subject data, etc.). An Amendment can be created by repository personnel with edit rights on the approved application, but only the repository director can submit it for review. After submission, the Amendment is locked and no further changes can be made unless requested by a reviewer. Only one Amendment per Repository Application can be in progress at a time.

Overview Once a Repository Application has been approved, a Continuing Review can be created to establish a new approval interval. A Continuing Review (CR) can be created by repository personnel with edit rights listed on the approved application, but only the repository director can submit it for review. After submission, the Continuing Review is locked and no further changes can be made unless requested by a reviewer. Only one Continuing Review submission for a Repository Application can be in progress at a time.

Overview Incident Reports are the equivalent of the AE/ORIO submission for a HUM application. An Incident Report is submitted when a significant incident occurs that requires acknowledgement by the IRB. An Incident Report (IR) can be created by repository personnel with edit rights listed on the approved application, but only the repository director can submit it for review. After submission, the IR is locked and no further changes can be made unless requested by a reviewer.

Overview A Termination Report is submitted only if all activity governed by the repository’s procedures will end permanently. A Termination Report can be created by repository personnel with edit rights listed on the approved application, but only the repository director can submit it for review. After submission, the Termination Report is locked and no further changes can be made unless requested by a reviewer. Only one Termination Report or Continuing Review submission for a Repository Application can be in progress at a time.

Overview Study Team Members and Core Committee Staff can use the Create Participating Site Application activity from the Multi-Site (parent) Study workspace to create a project application for external sites with University of Michigan as the IRB of record. Navigation Role: PI/Study Team Member or Core Committee Staff > My Home > Study workspace

Overview Study teams receive an email reminder that their research application is due for a Scheduled Continuing Review (SCR) 30, 60, and 90 days prior to the study expiration date. Create an SCR to renew or terminate your study. Navigation Role: PI/Study Team Member > Home Workspace

Overview Study teams are required to submit Adverse Events (AEs) and Other Reportable Information and Occurrences (ORIOs) via eResearch Regulatory Management (eRRM). AE/ORIO reports can also be created to follow-up on previously reported AEs/ORIOs.

OverviewNew study applications created in eResearch Regulatory Management (eRRM) are routed to the appropriate review committee(s) upon submission, based on information entered in the application. You can start a new study application and save it for completion at a later time.Important Information

OverviewIf a submission was approved with contingencies, and the contingencies addressed by the Study Team require a review by the committee members prior to final approval, then IRB Staff will send the submission to a Designated Reviewer(s) to complete the contingency review.Designated Reviewers asked to review a submission will be notified via email. Reviewers should access eResearch Regulatory Management (eRRM) submissions assigned to them via the email link (e.g. REV00123456).