Declaration of Interest

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    • #5031
      Michal Fryza

      Dear All,

      I am looking for any recommendation on proper classification to be used for Declaration of Interest filing. This applies to Principal Investigators at European sites under Regulation (EU) No. 536/2014 Clinical Trials on Medicinal Products for Human Use.

      05.02.10 Financial Disclosure Form appears to be the right one. Do you agree?

      Kind regards,


    • #5032
      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,

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