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Clinical investigator financial disclosure

This article was originally published in The Gray Sheet

Executive Summary

FDA guidance document encourages industry to collect financial records from their clinical trial investigators "in as efficient and least burdensome manner as possible," suggesting the use of questionnaires as opposed to "elaborate internal computerized tracking systems." Disclosure of compensation to clinical investigators conducting studies of products, as well as the investigators' financial interests in study sponsor companies, is required under a Feb. 2 rule. The agency is requesting comments on the guidance, which also addresses industry concerns about the costs of collecting and maintaining the financial records

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