1. Purpose
This SOP describes the guidelines that WVU researchers should follow regarding research data retention and destruction when closing a research project.
2. Overview
Researchers should retain signed documents and other information required by the sponsor, the federal agency regulating the research (i.e., DHHS OHRP, FDA, etc.), and the institution as required by regulatory requirements and institutional policy.
Records must be accessible for inspection and/or copying by authorized WVU OHRP and IRB representatives, other assigned WVU authorized officials, officials of federal and state regulatory agencies, HHS Office for Human Research Protections (OHRP), the Food and Drug Administration (FDA), and accrediting bodies.
This policy applies to both paper and electronic files. The WVU electronic protocol submission system, and other research systems provided such as REDCap retains and archives protocol and research information according to WVU policy. The PI should ensure retention requirements if other non-WVU electronic systems are used to conduct the research. For additional information on WVU’s Record Keeping and Destruction Retention Policies, see the WVU Record Retention & Policy Schedule in the References section of this document.
3. Retention and Destruction Procedures
3.1 The researcher maintains signed documents (e.g., signed consents/assents) and records related to the research project for at least three (3) years after the project is closed, taking measures to prevent accidental or premature destruction of these documents. The researcher maintains any HIPAA-regulated documentation as outlined by HIPAA and WVU policies (typically up to 6 (six) years). Researchers store records consistent with the plan approved by the IRB and the institution in a secured manner to prevent breaches of confidentiality.
3.2 For research under the authority of FDA or other regulatory agencies, the researcher retains signed documents and records related to the research project for the period specified in the applicable regulations if the requirements are longer than three (3) years after closing the research project. For multi-site research projects, the researcher consults the sponsor regarding retention requirements but must maintain records for a minimum of six years after the research project closes.
3.3 The researcher ensures that retained records are accessible for inspection and/or copying by authorized representatives of institutional or regulatory agencies.
3. References
WVU Policies:
WVU Policies:WVU Policy G1- Record Retention; Policy Schedule