For medical colleagues, responsibilities specified by the terms “principal investigator” and “head of the clinical trial” arise from §3 Sec. 5 and Sec. 6 of the German Medical Devices Implementation Act (translated by MEDIACC, Medizinprodukterecht-Durchführungsgesetz [MPDG]) in accordance with German regulations in addition to Art. 2 No. 45 MDR (EU) 2017/745. This regulation corresponds to that from §9 Sec. 1 of the Ordinance on Clinical Trials with Medical Devices (translated by MEDIACC, Verordnung über klinische Prüfungen von Medizinprodukten [MPKPV]). The background is that the responsibility of the respective ethics committee is derived from this.
At a clinical trial site, the “principal investigator” is responsible for managing a group of investigators on site, while the “head of clinical study” is appointed by the sponsor to manage clinical trials conducted in multiple trial sites or other clinical trials. The requirements for investigator, principal investigator and head of clinical study are specified in §30. They essentially coincide with the previously applicable requirements in §20 Sec. 1 Number 4 of Medical Devices Act, according to which a head of clinical study has to demonstrate 2 years of experience in clinical trials of medical devices. Experience in performance studies with residual samples or those that have no influence on patient management, on the other hand, is not sufficient.
The general obligations for investigators and principal investigators, as well as reporting obligations, pseudonymization of personal data for transmission, self-responsible corrective actions are found in §62, §63, §65 and §66.