Many regulations are open to interpretation, but we run into a simple error frequently in our inspection readiness and audit activities that has a pretty simple solution: Don’t use FDA Form 3454 or 3455 to collect financial disclosure information from clinical investigators. These forms are intended to be sent by the sponsor to FDA to report financial disclosures from individual investigators (3455) and certify that other investigators have no interests to disclose (3454). As such, they are not designed to capture clear information in a situation where the investigator might or might not have interests to disclose.
Frequently, Form 3455 is used in error to collect financial disclosure information from investigators, because it looks very similar to forms that are typically used. If you look closely at the header, though, it states, “The named individual has participated in financial arrangements or holds financial interests that are required to be disclosed as follows:” This statement is followed by four categories of arrangements (value of compensation could be influenced by the outcome; significant payments; proprietary interest; and equity interest). There is no box for an investigator to indicate that they don’t hold any of these interests. Investigators with no interests to disclose may be told to sign the form without ticking any of the boxes; but because the header indicates that the signatory does have financial interests to disclose, signing the form does not clearly indicate that no interest exists. At best, it’s ambiguous.
FDA has addressed this issue in its Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators:
To ensure clarity in financial disclosure reporting (and to avoid an inspection finding), use a form designed to collect either a positive or negative disclosure, with all the revelant details. Save the 3455 for your final report to the agency.