Good Clinical Practice
The German decree for the application of the international guidelines of “Good Clinical Practice” (GCP) for clinical studies in Germany are enacted, it places the rights, safety and well-being of the trial participant above all else. See link below.
Further, it lays out standards for the ascertainment and documentation of data in order to ensure the comparability and therefore credibility of study results. A clinical study is only allowed to start after the all-embracing ethics committee confirm that the expected benefit outweighs the inconvenience and the foreseeable risks.
Further, the ethics committee of the General Medical Council Hamburg first checks the qualification of doctors and study personnel.
Before the start of the study the candidate is extensively informed about the planned study. His consent to the participation of the study is explicitly voluntarily. A trial participant can withdraw from the study at any time without giving reasons.
Link: GCP Ordinance – GCP-V