Document Management Storage and Retention

Upon completion of a research study, all study specific documents must be maintained on site in storage for 1 year unless otherwise stated in the research study contract or as required under Federal Regulations. After which, files must be securely archived in an off-site facility, where they must remain retrievable for 7 years unless otherwise stated in the study specific agreement. For assistance with record storage, please contact the Trinity Health Office of Research & Innovation – West Michigan by submitting a consultation request.

Helpful Links

Institutional SOPs:

• ip06-105 – Record Retention (Word, 78KB)

Institutional Review Board SOPs:

• FO 305 – Documentation and Document Management (PDF, 368KB)

Research & Innovation SOPs:

• GA 105 – Records Management, Accounting and Retention (PDF, 328KB)
• GA 105A – Request for Medical Records (PDF, 328KB)
• GA 105B – Request for Password for Electronic Medical Records (PDF, 41KB)
• GA 105C – Telephone Contact Log (PDF, 61KB)
• GA 105D – File or Document Access Log (PDF, 66KB)
• GA 105E – Storage Label or Cover Sheet (PDF, 74KB)

FDA Code of Federal Regulations:

• 21 CFR 312.62(c) – Investigator recordkeeping and record retention