Site operations

Record retention: what sites must keep, for how long, and who pays

By TrialNotice · Updated
Overhead view of a coordinator organizing five color coded study binders beside lab kits and a planner
Short answerUnder 21 CFR 312.62(c), investigators keep drug study records for 2 years after a marketing application is approved for the indication, or, if no application is filed or approved, until 2 years after the investigation is discontinued and FDA is notified. Sponsor contracts often require longer, sponsors tell sites when records may be destroyed, and HIPAA documentation is commonly kept for 6 years. Storage for that long costs money, so it belongs in the budget.
General information, not legal advice. Follow your contracts, sponsor instructions, IRB, and institutional policy.

What does FDA require?

For drug studies, investigators retain required records for 2 years after a marketing application is approved for the drug for the indication studied; if no application is filed or it is not approved, until 2 years after the investigation is discontinued and FDA is notified (eCFR). Device investigators keep comparable records under 21 CFR 812, including device receipt, use, and disposition, and each subject's exposure (NIH).

Which other rules apply?

Record typeTypical minimum retention
FDA regulated study records2 years after approval or discontinuation (eCFR)
IRB records3 years after study completion (CHOP)
HIPAA authorizations and waivers6 years after study completion (CHOP)
Sponsor contract requirementsOften longer; the sponsor notifies the site when records may be destroyed

Institutions may set longer periods than FDA, as UNC does (UNC Chapel Hill).

What must be kept?

  • Consent forms and case histories for every participant.
  • Investigational product disposition records.
  • Delegation logs, training records, and regulatory correspondence.
  • Source documents supporting every data point.

Who pays for storage?

It should be the sponsor. Published fee schedules include $750 to $1,000 for document storage or archiving (LSU Health; St. Luke's). Because retention can run many years past the last visit, sites should negotiate a storage fee covering the full period, plus a fee if the sponsor later extends it.

How do sites manage it?

  1. Never destroy records without written sponsor approval.
  2. Log each study's retention trigger and expected end date.
  3. Use secure offsite or electronic storage with retrieval for inspections.
  4. Plan for ownership changes: retention obligations follow the records. See integrating an acquired site.

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Sources

  1. eCFR, 21 CFR 312.62, Investigator recordkeeping and record retention
  2. NIH Office of Human Subjects Research Protections, Record Retention
  3. Children's Hospital of Philadelphia Research Institute, Document Retention
  4. UNC Chapel Hill, Investigator Records: Retention and Disposition FAQs (2024)
  5. LSU Health New Orleans Clinical Trials Office, Budget Development training
  6. St. Luke's University Health Network, clinical trial budget template

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