21 CFR 312.62 - Investigator Recordkeeping and Record Retention

What it says

An investigator must maintain adequate records of the disposition of the investigational drug, including dates, quantity and use by subjects, and must prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each subject. These records, including case report forms and supporting data such as signed consent forms and medical records, must be kept for two years after a marketing application is approved, or two years after the investigation is discontinued and FDA is notified.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Case histories must show that each subject met the protocol criteria and that consent was obtained.
• Source documents should support every entry in the case report forms.
• Drug accountability should reconcile what was received, dispensed, returned and destroyed.

What FDA inspectors look for

• Whether case report form data match source documents.
• Whether drug accountability records reconcile.
• Whether records are retained for the required period.

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