Financial Disclosure Forms
For some commercial studies, the PI and sub-Is may be asked to complete and sign financial disclosure forms (FDF). The information below explains what an FDF is and why sponsors ask for them.
What are Financial Disclosure Forms?
The purpose of a Financial Disclosure Form (FDF) is for the PI and Sub-Is to disclose any financial interests they may have in the outcome of the clinical trial.
Often companies will use the United States Food and Drug Administration template FDF form (FDA 3455 Disclosure: Financial Interest and Arrangements of Clinical Investigators), but they may also use their own template.
You can find an example of the FDA 3455 form by searching for it on the FDAs webpage here.
Who Signs a FDF?
The PI and Sub-Is may be asked to sign FDFs.
FDFs are not a UK requirement, but if a company is planning to submit a marketing application in another country (such as the US), they may be required to provide these forms as part of their application.
The regulation in the US requires certification of the absence of certain financial interests and arrangements of clinical investigators that could affect the reliability of data due to bias. If there are any financial interests, these must be disclosed and information on arrangements taken to minimise any potential for bias provided.
Completion of FDF forms often form part of the documents required for a site to be given the green light to start recruitment.