Submission Einreichung
Before a clinical trial can be conducted, it has to be approved by the higher federal authority and granted a favorable decision by the responsible ethics committee. During a written application by the sponsor in Germany, the following documents need to be submitted in German and English language, in accordance with § 7 Par. 2 – 4 GCP-Ordinance:
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
Deutsche Erklärung