Research Records - records maintained by investigators detailing research conducted by faculty and students (including research on human subjects).
Retain records relating to investigational new drugs for the longer of 5 years after research results are submitted to the U.S. Food and Drug Administration (FDA) in support of an application for a research or marketing permit OR 2 years after a marketing application is approved for the drug for the indication for which the drug is being investigated. If no application is filed, retain for 2 years after the investigation is discontinued and the FDA is notified, then destroy.
Retain records relating to investigational devices for the longer of 5 years after research results are submitted to the U.S. Food and Drug Administration in support of an application for a research or marketing permit OR 2 years after the investigation is discontinued/completed OR 2 years after the records are no longer required to support a premarket approval application or a notice of completion of a product development protocol, then destroy.
Retain medical records of minors for 7 years after completion of the research or until the minor has reached age 21 (whichever is longer), then destroy.
Retain all other research files for 7 years after the completion of the research or for a longer period of time if required by sponsor contract, then destroy.
See Item 197-Institutional Review Board (IRB) Records and Item 198-Research Misconduct Records for related requirements.