What documents related to IRB review should be maintained by the study team as part of the research record?

Frequently Asked Question

Part of the responsibility of study teams is to maintain a record of regulatory documents, in addition to other study related documents.  One of the benefits of the transition to the ARROW system for IRB review is a better means for tracking which documents the IRB has approved and any changes made to documents. Study teams should use ARROW to ensure they are working with the most current versions of IRB-approved documents, including protocols, recruitment materials, study instruments, and consent and HIPAA documents. Study teams are expected to be able to easily ascertain the correct (approved) version of documents that have been reviewed by the IRB.  Failure to use the approved version of documents that have been reviewed by the IRB can result in non-compliance, and require reporting to the IRB.

Minimum documentation study teams are responsible for keeping related to IRB review of human subjects research includes the following:

For further guidance on materials that require IRB review and approval, please see the following guidance: Guidance Regarding Types of Supporting Materials that Require IRB Review and Approval

Study teams are required to keep other documentation related to the conduct of human subjects research beyond those related to the IRB review and approval process. The UW Institute for Clinical and Translational Research (ICTR) has developed a Clinical Research Toolkit  to assist study teams throughout the study process; including a “Regulatory Binder Guidance” that provides additional information on what materials should be kept.