Financial Disclosure to FDA – New Draft Guidance Available

Yesterday, 24 May 2011, the Food & Drug Administration (FDA) released for public review and comment a draft revision of the guidance for financial disclosure by clinical investigators. This will replace the last guidance issued back in 2001.

The revised guidance provides additional clarification on the rules for financial disclosure; no changes to the rules themselves are being introduced by the guidance document. The guidance confirms that financial disclosure forms are not submitted as part of an IND/IDE but as part of a marketing application. Sponsors should therefore have systems in place to adequately manage these records until they are needed for submission. The guidance also clarifies the expected level of due diligence in the event that the sponsor has difficulties obtaining information directly from clinical investigators. Sponsors may be asked to demonstrate that due diligence has been followed, so keep appropriate records of this. However, the FDA do note that they “do not require sponsors to establish elaborate tracking systems to collect financial information”. So the message is: keep it simple, keep it accurate, keep it until needed.

With respect to record keeping systems however, it should be noted that financial interest information should be retained for 2 years following the date of approval of a marketing application. Systems should therefore be in place to facilitate the removal and destruction of financial interest information once this time period has expired, remembering that information on file may also relate to other marketing applications.

One area that does not appear to be covered in the guidance is that of data protection / data privacy. With the increasing use of electronic document management systems (eTMFs) amongst sponsor companies, there is some concern that access to financial information may become available to a wider audience than was previously available when filing systems were in hard-copy. Remember that financial disclosure obligations also include the clinical investigator’s spouse and dependent children. Have they given consent to their personal data being disclosed to everyone in the sponsor’s company?

Comments to the FDA are due by 25 July 2011.

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About rammellel

Records management consultant to the life sciences / pharmaceutical industry
This entry was posted in Regulations, TMF. Bookmark the permalink.

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