September 18, 2024—We are pleased to announce the release of two new resources designed to assist investigators with the retention and disposition of clinical research investigator records:
- Investigator Records: Retention and Disposition FAQs: This FAQ document addresses common questions about investigator records, including definitions, retention periods, and specific requirements for different types of research. It also explains the difference between record retention and disposition, and provides guidance on handling records subject to HIPAA, FDA regulations, and other specific circumstances.
- Investigator Record Retention Decision Tree: This tool helps you identify the appropriate record type and apply the requirements of the UNC General Records Retention and Disposition Schedule. It provides clear guidelines on how long to retain records based on various scenarios, ensuring compliance with federal, state, and local regulations.
Takeaway:
- Apply the longest applicable retention standard for the investigator record, but no less than three years following the completion of the research.
These resources are designed to ensure that all investigators at UNC-Chapel Hill are equipped with the necessary information to manage their research records effectively and in compliance with all applicable regulations.
For more detailed information, please refer to the linked documents or visit the Clinical Research Compliance Office (CRCO) Resource Hub. If you have any questions, feel free to contact the CRCO.