Home Forums EU Clinical Trial Regulation Impact Declaration of Interest Reply To: Declaration of Interest

Eldin Rammell

Hi Michal,

I agree with your conclusions. Although we often associate financial disclosure forms with FDA regulations, the requirement is not exclusive to the FDA. The artifact description in the Reference Model states:

“To document financial disclosures, certification documentation and conflicts of interest, which include but are not limited to: completed disclosure forms of financial interests and arrangements of clinical investigators”

so any form that fulfils this criteria is correctly filed here, including the new EU ‘Declaration of Interest’ form.

Kind regards,