Human Subjects Record Retention

The Federal regulations on human subject protection in research require that all research-related records be retained for at least 3 years after the study has been completed. Individual funding sources, federal or private, may have increased record retention periods; check your funding source for this information. For externally funded studies, information about financial record retention requirements is provided by the Records Compliance.

All research records at the University shall be accessible for inspection and copying by the IRB, the IRB Monitor, Research Compliance Services and applicable federal agencies or research sponsors.

IRB staff will retain records in accordance with Federal regulations.  Connecticut currently has no required retention period for IRB records.

IRB Study Records

The ORC will maintain complete files of all active studies on site.

The IRB staff arranges to have closed study files moved to a permanent, secure location in the basement of the Whetten Graduate Center for archiving.  Files may not be destroyed until after Federal retention requirements are met.  A list of closed files is available from the InfoEd database.  Files are retrievable immediately for future reference to allow for inspection and copying by regulatory agencies, including the OHRP and FDA, at reasonable times and in a reasonable manner.

IRB Meeting Documentation

The IRB staff maintains a hard copy of the agenda and meeting minutes in 3-ring binders.  Hard copies of the approved list of exempt and expedited protocols, a status report of protocols previously reviewed at IRB meetings, and educational materials are also attached to the minutes and retained in the binder.  A hard copy of the minutes is also provided to the IO.  The IRB staff also maintains electronic copies of the agendas and minutes for a given calendar year in a folder shared by the ORC and IRB staff.  The IRB staff maintains hard copy files of meeting documentation on site for at least three years.  The IRB staff may archive these files as dictated by space needs.  Files are not destroyed.  Files are retrievable immediately to allow for inspection and copying by regulatory agencies, including the OHRP and FDA, at reasonable times and in a reasonable manner.

Investigator Study Records

Per federal regulations (45 CFR 46.115(b) and 21 CFR 56.115(b)), investigators must maintain research records for three years beyond the completion/termination of the study.

Per FDA regulations for investigational new drugs (21 CFR 312.62) investigators must retain records for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it was investigated; or, if no application is to be filed, or if the application is not approved for such indications, until 2 years after the investigation is discontinued and the FDA is notified.

Per FDA regulations for Investigational Devices (21 CFR 812.140) an investigator or sponsor shall maintain the study records during the investigation and for a period of 2 years after the latter of the following two dates: the date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.  An investigator or sponsor may withdraw from the responsibility to maintain records for the period required and transfer custody of the records to any other person who will accept responsibility for them ( including the requirements of § 812.145). Notice of a transfer must be given to FDA no later than 10 working days after transfer occurs.