- A brief description of the financing of the study, including information about the financial source(s) and what this funding cover. It is assumed that the intervention period is financially secured.
- Description of any compensation for the study participants. This also includes a description of how participants’ eventual expenses are to be reimbursed. It is recommended to use the European Commission’s template Compensation for trial participants.
- Document providing an overview of any agreements between the sponsor and the trial sites involved, as well as any compensation arrangements that applies to the trial sites and/or PIs involved. The agreements are not to be submitted.
- All circumstances, such as financial interests and institutional affiliations, which may affect the PIs impartiality must be described for each PI in the Declaration of Interest Form template or in another separate document.
Please note that the document Proof of Payment should only be submitted under Part I, this also applies for substantial modification applications.
