The purpose of the Archiving 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.

Related Resources

UM Institutional Review Boards Medical School (IRBMED) Record Keeping Guidelines

HRPP Operations Manual (OM)

Standard Practice Guideline (SPG) Templates for Clinical Trials

Downloadable Templates and Appendices


Appendix A Record Disposition.docx

Appendix B Record Destruction.docx


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