The Center for Biologics Evaluation and Research’s (CBER) Bioresearch Monitoring Program released a new investigator Warning Letter October, 2018. Interestingly, the category is listed as IRB. The investigator was involved with a clinical study of influenza vaccination in the pediatric population.
Some findings of note were:
Subjects were entered into the Interactive Web Response System (IWRS) as randomized although consent from parents was not obtained, and the response letter states that both parents refused participation for their children.
Eight subjects were enrolled despite meeting exclusion criteria.
At least three subjects were not properly randomized and received the wrong number of doses according to the US Advisory Committee on Immunization Practices as referenced in the protocol for the randomization plan.
Three subjects received vaccine although they were using a drug that would exclude them from participation.
At least three subjects had missing or inconsistent source documentation, including data changed from call not made to data entry at a later time.
At least six subjects did not have proper documentation of informed consent, including times being changed from after vaccination to before vaccination or parents signing after the investigator.
By reviewing publicly available Warning Letters, one can determine common FDA findings as well as how the subject of the inspection responds and how the FDA reacts to the response. Of particular interest to the FDA is the corrective and preventive action plan. In this case, the investigator’s Response Letter describes adequate corrective and preventive action plans as long as they are carried out as described.
-The Clinical Pathways Team
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