Document |
Higher Federal Authority |
Ethics Committee |
Signed protocol |
x |
x |
Information on the sponsor, the study sites, investigators, and the principal investigator |
x |
x |
Investigator’s Brochure (IB) |
x |
x |
Choice of patients/subjects and rationale |
x |
x |
Investigator Medicinal Product Dossier (IMPD) or Summary of Product Characteristics (SmPC) |
x |
|
Benefit-risk assessment |
|
x |
Information regarding the funding of the clinical trial |
|
x |
Proof of qualification for the investigators and the members of the study staff (CV, GCP certificate) |
|
x |
Information on possible economic interests of the investigators (financial disclosure) |
|
x |
Information on the suitability of the study sites |
|
x |
Information and documents received by the patients/subjects (patient information and informed consent form, advertising material) |
|
x |
Description of the procedure for obtaining consent after informing |
|
x |
Remuneration of investigators and compensation of patients/subjects |
|
x |