- Overview
- Records to Keep While a New Study is Being Reviewed by the IRB
- Records to Keep Once a Study is Approved by the IRB
- Protocol Modifications Submissions
- Continuing Renewal Submissions
- Record Retention Requirements
- IRB Learning Shot: Source Documentation
The IRB maintains an official protocol file for each study to meet the University's regulatory obligations for record keeping. The IRB staff is not responsible for maintaining study documents for the researchers, or for providing copies of official documents to research staff. Keeping accurate and complete protocol records is the responsibility of the study team.
The following guidelines are provided to assist investigators and research staff with recordkeeping of approved IRB protocol documents and to facilitate submissions of correct versions of protocol documents for the life of the study.
Records to Keep While a New Study is Being Reviewed by the IRB
The study team should keep electronic files of all study documents (e.g., protocol, informed consents etc.) in order to make requested revisions that may be required for IRB approval.
Records to Keep After a Study is Approved by the IRB
All documents submitted to the IRB should be retained by the study teams. Any document submitted to and reviewed by the IRB-HSR after October 2019 is available in an electronic format in IRB Pro.
Protocol Modifications Submissions
- The study team must incorporate revisions into the most recently approved electronic file version of the protocol and consent form(s), and other protocol documents, as applicable.
- Note that some studies are modified frequently and the most recent approved version must always be used for each new modification request.
- Versions checks of protocols and consent forms are performed routinely by the IRB staff. Revisions submitted on older versions of the protocol or consent cannot be reviewed by the IRB and will be returned for correction.
Continuing Renewal Submissions
- The study team must keep copies of all documents, including the Status Forms, submitted to the IRB at the time of the continuation review.
The study team should contact the University Records Officer within the UVA Information Security Office to determine when study files may be destroyed.