No. FDA regulations do not require a CV or other statement of qualifications to be updated during a clinical study. However, a sponsor may require CV updates. In addition, the regulations DO require that you have the necessary education and experience to perform your job. If your CV is more than two years old, the necessary evidence may be lacking. USDM Life Sciences recommends you adhere to sponsor requirements that are provided during the trial.
According to page 11 of the Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs, “Section #2 requires the investigator to attach a curriculum vitae (CV) or other statement of qualifications, showing the education, training and experience that qualifies the investigator as an expert in the clinical investigation of the drug/biologic for the use under investigation. Information identified in this section should be attached to Form 1572 which enables the sponsor to assess an investigator’s qualifications.” Form 1572 is required to be updated if the investigator is added to another protocol in the study. For additional information, reference the information sheet.
At USDM Life Sciences, we have more than 100 years combined experience in regulatory compliance, quality assurance, quality systems, and auditing. USDM’s Global Audits Practice Team perform audits on pharmaceutical, biotech, and medical device companies in the United Sates and abroad.
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