Regulatory Management

Overview This document provides information that Core Committee Staff members can use to manage submissions for human subject research in eResearch Regulatory Management (eRRM). Approval and Expiration Dates The following table details how approval and expiration dates are set in eRRM.   If it is determined that a Continuing Review is required, then the approval and expiration dates described below apply.
Overview A Continuing Report (CR) is used to renew the approval of a participating site application. Study teams receive an email reminder that their site application is due for a scheduled continuing review 30, 60, and 90 days prior to the study expiration date.  A CR can be created by personnel with edit rights on the approved participating site application, but only the Principal Investigator can submit it for review. Only one Termination Report or Continuing Report for a site application can be in progress at a time.
Overview A Termination Report is used only for terminating an approved participating site application upon completion of the research or for other reasons, such as low accrual, toxicity, funding, etc. Once the report is finalized, the site application will be terminated and archived. Once archived, you cannot modify or use the site application for research going forward. Important Only one Termination Report or Continuing Review for a site application can be in progress at a time.
Overview Once a study application has been approved, an amendment must be created to document changes to the study (e.g., changes to study team, sponsors, subject populations, etc.). An amendment can be initiated by any Study Team Member listed on the approved application, but it can only be submitted for review by the UM Principal Investigator. After submission, the amendment application is locked and no further changes can be made unless requested by a reviewer. Only one amendment can be in process at a time for a study.
Overview An Incident Report is submitted when a significant incident occurs that requires acknowledgment by the IRB.  Adverse Events (AE) include any experience or abnormal finding that is harmful or increases the risk of harm to research participants. Other Reportable Information or Occurrence (ORIO) includes audits, other reports, protocol deviations, protocol violations, facility/data accidents, and complaints (which includes lapses in approval).
Overview Once a Participating Site Application has been approved, an Amendment must be created to document changes (e.g., changes to team members, subject populations, etc.). After submission, the Amendment application is locked and no further changes can be made unless requested by a reviewer. Only one Amendment can be in process at a time. Once approved, the Amendment is accessed through the original application under the Amendments tab.
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.