Institutional Review Board for Health Sciences Research (IRB-HSR)

Managing Protocol After Initial Approval

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 protocols 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 Once a Study is Approved by the IRB

Hard Copies

Electronic Copies

Protocol Modifications Submissions

Continuing Renewal Submissions

Record Retention Requirements

The study team should contact the University Records Officer within the UVa Information Security, Policy and Records Office at 434-243-9162 to determine when study files may be destroyed.

Last Modified: Wednesday, 12-Jul-2017 13:21:28 EDT