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700-39-IRB Document Management

Title: IRB Document Management
Owner: IRB
Last Update/Revised: 05/01/2024

Policy: IRB files are maintained in a manner that contains a history of all IRB actions related to the review of all submissions and either the determination of a project or study (in the case of not human subjects research or exempt research), or approval of proposed research (via expedited and full board review). Additionally, files are maintained for continuing reviews, amendments, event reporting forms, and final project reports.

Regardless of the disposition of a submission (determination, approval, disapproval, etc.), a record is kept. These records indicate what documents the IRB has reviewed.

Purpose: This policy describes how documents related to the IRB are managed and stored.

Procedures:

1. Project/Study-Related Documents - The IRB Office retains all records regarding a complete submission indefinitely. Documentation will be maintained in the IRB Google Drive. Retained documents include but are not limited to:

  • all documents included with a complete submission (incomplete submissions are not stored)
  • agendas and minutes of all IRB meetings
  • copies of all submitted reports and other continuing review activities
  • copies of amendments, event reports, and final reports
  • copies of all correspondence between the IRB and the investigators

2. IRB Administration Documents - The IRB maintains and retains all records regarding IRB administrative activities indefinitely. Documents include:

  • current and previous copies of the SOP Manual
  • Federalwide Assurance with OHRP
  • IRB registration with OHRP

3. Documents not Maintained - Material received by the IRB in excess of the required original documentation and appropriate forms or incomplete materials will not be stored on the IRB Google Drive. For example, if a doctoral student submits an incomplete IRB submission, that submission will not be archived. 

Scope: This policy applies to documents submitted to the IRB as well as IRB administrative documents.

Documents and Forms:

None