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FDA Guidance Clarifies Process for Disclosing Conflicts of Interest in Clinical Trials

Published March 13, 2013 by OSP


In an effort to combat confusion around the requirements in 21 CFR 54 (Financial Disclosure by Clinical Investigator), the FDA has released guidance documents to clarify the financial disclosure requirements by clinical investigators that could influence the outcome of a trial or have the potential for investigator bias. Thus, FDA requires applicants to submit a list of all investigators who will be working on the trial paired with a certification that either no financial arrangements exist that would cause a problem, or explaining the nature and extent of those holdings and why they do not pose a problem to the conduct of the trial.

 The guidance also contains a number  answers to common questions, such as methods to reduce bias, required forms and formatting, responsibilities, due diligence procedures, reportable payments and interests (including 401k investments), the definitions of various entities involved in a trial, how outsourcing a trial affects reporting requirements, and various other requirements associated with reporting financial interests.

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