Overview
The purpose of the Archiving Standard Practice Guideline (SPG) is to document a process for long-term storage of all clinical research related records. Related records include, but are not limited to, subject research files, regulatory information, e-mail, telephone records, and other correspondence. Following a thorough and consistent process will allow for more efficient tracking and retrieval of research records.
Research teams should identify/define:
Roles and responsibilities of research team members during the archive process
Method(s) for storing the archived records (e.g. electronic, paper, CD)
Naming and labeling conventions for archived records
Storage location (e.g. U-attic, locked room, file cabinets with limited access, etc.)
Method for tracking, retrieving, transferring, and destroying archived records
Remember: Record retention obligations may vary depending on the nature of the research. Because different regulations apply to different types of clinical trials, there is not a simple answer as to how long you will have to retain clinical research records.
When working with an industry sponsor, review your project's specific requirements. The sponsor may request that you obtain their approval prior to destroying any files.
Downloads
Archiving
Appendix A Record Disposition
Appendix B Record Destruction
Questions?
Contact us at MICHR-SPGSupport@umich.edu.