How long do I keep records, and which records am I required to maintain?
The eIRB+ system is the IRB Office’s tool for keeping and maintaining records. It does not meet the institutional requirements for PI documentation. The IRB Office provides the Research Records and Regulatory Binder templates to assist investigators in maintaining research documentation in compliance with requirements and best practices.
- The Principal Investigator must maintain clear and compliant research documentation throughout the life of the study, including but not limited to:
- All IRB-approved versions of protocol and consent documents;
- All IRB-approved participant-facing materials (recruitment materials, participant brochure, etc.);
- Copies of IRB approval letters; email correspondence with IRB;
- Copies of current human participant training certificates for study personnel (CITI Training);
- The PI must document study team training, qualifications, and delegation of responsibilities. The IRB Office provides the Delegation of Authority Log (DOA) tool to help you meet this requirement.
Maintain your Human Research records, including signed and dated consent documents, in accordance with the following policies found in the University Policy Catalog:
- Research Data: Ownership, Retention and Access
- Retention of University Records
- Retention of University Records: Appendix A – Records Retention Schedule
- And the IRB Office’s GUIDANCE: Research Document Retention Requirements for Principal Investigators (HRP-1914).
You must retain regulatory and IRB records for IRB-reviewed studies in accordance with applicable policies, even if you have not enrolled any participants or abstracted any data. If your Human Research is sponsored, contact the sponsor before disposing of Human Research records.