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Document Management Storage and Retention


A lab worker conducts research using test tubes

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:

Institutional Review Board SOPs:

Research & Innovation SOPs:

FDA Code of Federal Regulations: