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QRTI Newsline --- Wednesday September 8, 2010

Are Your Investigators Keeping Records for 20 Years?

By Phyllis B. Kent

An FDA 2009 warning letter (01/14/09) cites deviations in a consent that was given over 20 years ago, October 6, 1988! The warning letter also cites missing informed consents and failure to maintain records for the required time.

“You failed to retain records for the requisite time period 121 CFR 312.57(c)].

21 CFR 312.62(c) requires that a sponsor retain the records and reports required by 21 CFR Part 312 for 2 years after a marketing application is approved for the drug; or, if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.”

Few Clinical Investigators would think that FDA would be reviewing 15-20 year old documents. However, the Warning Letter shows this to be the case,

“Regarding study [(b)(4)], study procedures were conducted prior to obtaining informed consent from subjects [(b)(4)] and [(b)(4)]. Specifically, for subject [(b)(4)], an MRI of the brain was conducted on 10/4/88, but informed consent was not signed by the subject until 10/06/88. For subject [(b)(4)], a liver biopsy was performed on 10/4/94, but informed consent was not signed by the subject until 10/5/94.”

The full letter can be viewed at the link below. Monitors can provide this letter to clinical site staff to make Clinical Investigators aware of this warning letter to help drive home the point of record retention requirements.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm152450.htm