FDA Warning to Pediatrician on Adverse Events


A pediatrician conducting a vaccine study received an FDA Warning Letter for failure to report adverse events as required by the protocol along with other GCP violations. The Warning Letter noted numerous adverse events not reported. Although the title of the study has been redacted, it is appears from the nature of the adverse events, such as ear infections, that it was for a pediatric vaccine. FDA prioritizes the review of studies when there are risks to children, a vulnerable population, in a clinical trial. The letter was issued by the Center for Biologics Evaluation & Research.

FDA Warning

Adverse Events in Vaccine Clinical Trial

The FDA Warning Letter, dated March 11, 2010, also cited the pediatrician for failure to record concomitant medications, failure to maintain adequate and accurate case histories, and records of the disposition of the investigational drug. These are the types of violations that FDA has cited time and again, following the protocol for reporting adverse events and other activities such as concomitant medications and serious recordkeeping errors. Protocol violations top the list of GCP violations. However there was an additional recordkeeping violation that is less common. The trial cited the clinical investigator for the failure to maintain records noting:

“At the time you signed the Form FDA 1572, Statement of Investigator, for Studies 1 and 2, you agreed to maintain adequate and accurate records in accordance with 21 CFR 312.62 and to make these records available for inspection in accordance with 21 CFR 312.68. In your letter, you explain that you do not have access to the study record because your affiliation with Sylva Pediatric Associates (SPA) ended in (b)(6). Our investigation revealed that after your departure from Sylva Pediatrics records of your completed studies were stored by (b)(4). After (b)(4) closed, your records were relocated to SPA and did not remain under your supervision at your current position at Western North Carolina Pediatric and Adolescent Care in Sylva, North Carolina.”

FDA Warning

The wrong place for study files


I have seen this happen on several occasions. A researcher will change their practice and lose control of their records. In the worst case I saw a breakup in the medical practice led to the study records being moved to a storage closet and then being thrown in a dumpster by a janitor. Bad news. However, the news is even worse when the research participants are children. Here is the Warning Letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204871.htm

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