Study Closure
Main Content
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
- 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.