Investigational Drug Record Retention Date (21 CFR 312.57, 312.62)
The earliest federal date for destroying investigational drug study records.
Open the tool → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.
Example
- Role
- Investigator (21 CFR 312.62(c))
- What started the clock
- The investigation (or shipment and delivery) was discontinued and FDA…
- Date of that event
- 2026-02-28
Result: Retain until at least February 28, 2028 (the federal minimum).
The tool opens with these values already filled in. Replace them with your own.
What you enter
- Role
- What started the clock
- Date of that event (YYYY-MM-DD)
- A longer retention date from the protocol, contract or state law (YYYY-MM-DD, optional)
How this is calculated
Citation
21 CFR 312.62(c) (investigators) and 312.57(c) (sponsors): records kept for 2 years after a marketing application is approved, or 2 years after the investigation or shipment is discontinued and FDA is notified. Read the sources: 21 CFR 312.62 ↗, 21 CFR 312.57 ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.