| Coordinating Investigator (CI) | Leiter der klinischen Prüfung (LKP) |
| In case of multicentre trials, the sponsor will appoint one the participating investigators to become coordinating investigator (CI) in accordance with § 4 sec. 25 Medicinal Products Act or § 3 sec. 30 Medical Devices Act. The ethics committee responsible for the coordinating investigator automatically becomes the central ethics committee, to which the application for the conduct of a clinical trial must be submitted (§ 42 sec. 1 AMG or § 22 sec. 1 Medical Devices Act). In case of multinational studies each participating country will appoint one coordinating investigator.
In accordance with § 40 sec. 1 No. 5 Medicinal Products Act, the coordinating investigator must provide evidence of at least two years’ experience in the conduct of clinical trials on medicinal products. The CI assumes the overall scientific responsibility during a trial and often participates in elaborating the protocol before the start of the trial. During the trial, they coordinate and counsel other study centres, assess AEs and SAEs and are responsible for making the necessary notifications, if applicable. Furthermore, the CI continuously updates the risk benefit report and participates in deciding about any premature trial termination. However, the overall responsibility for a trial remains with the sponsor. In exceptional cases, also non-physicians may be appointed coordinating investigator, “if their profession, owing to the scientific requirements and the experience in the care of patients that it calls for, qualifies them to conduct research on human beings” (§ 4 sec. 25 Medicinal Product Act). In this case, corresponding documents proving the qualification of the person concerned must be submitted to the ethics committee. |
Deutsche Erklärung |
