Research Recordkeeping Responsibilities

Overview 

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.  The electronic file of the currently approved protocol and consent form(s) if applicable should be retained for future IRB submissions such as modifications or continuations.

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.

Record Retention Requirements

Principal Investigators are responsible for maintaining study records in a secure location, until completion of the research and beyond the closure of the study, in accordance with state and federal regulations for research record retention as well as any requirements in the contract with the funding source or sponsor. Please reach out to UVA Records and Information Management for current storage requirement on research record retention timeframes. Additionally, the UVA Records and Information Management office must approve the destruction of study records prior to implementation.

See the IRB Learning Shot on Source Documentation