Study Closure

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Archiving Records


  • Archiving records refers to retaining and maintaining documents associated with a study after the completion of the research.


  • Research data collected during the course of clinical research involving human research participants shall be collected and retained in accordance with the UMMC policy on Research Data Retention 
  • UMMC requires the following to be kept in a secure location for at least six years. Note: Study sponsors may require longer record retention.
    • IRB-approved research protocol and all amendments;
    • All versions of the investigator's brochure;
    • All informed consent documents;
    • All recruiting materials;
    • All renewal applications;
    • All adverse or unanticipated event reports;
    • All correspondence to and from the IRB;
    • All raw data.
  • Please refer to 21 CFR part 312.62 (external site) for retention requirements for an IND trial, and 140(6)(d) (external site) for IDE trial record retention policies.