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Archiving Records

Definition

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

Policies/guidelines

• 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 
  • Policy on Research Data Retention - PDF
• 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.