Financial Disclosure Guidance Should Put Less Burden On Sponsors - HIMA
This article was originally published in The Gray Sheet
Executive Summary
FDA should revise its draft guidance on financial disclosures by clinical investigators to ensure that clinical data is not rejected if a sponsor is unable to obtain financial information from foreign investigators, the Health Industry Manufacturers Association contends in Dec. 23 comments to the agency.
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Clinical investigator financial disclosure
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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