Overview
For Participating Site (SITE), Repository (REP), and Biosafety/IBC (IBCA) applications, "View Differences" functionality provides a way to see the changes between submitted application versions.
Regulatory Management
Overview
A Participating Site Application is used to track data with human subject research conducted at another institution where University of Michigan (U-M) is the IRB of record. New participating site applications are completed and submitted to the appropriate review committee(s). A new Participating Site Application may be started and saved for completion at a later time.
Navigation
The Participating Site Application can be accessed via:
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.