Clinical trial manager

In the case of multicentre clinical trials, the sponsor appoints an investigator-in-charge (LKP). According to the AMG of 1976 § 40, paragraph 1, the head of the clinical trial must be a licensed physician and have at least 2 years of experience in conducting clinical trials. In contrast to the German directives, the EU directives do not provide for a clinical trial manager, but only for the investigator.

The LKP must present proof of qualifications such as further training in clinical studies and a GCP certificate. In addition, the head of the clinical trial must also provide evidence of professional qualifications such as specialist training. According to a joint resolution of the German Medical Association and the Working Group of Medical Ethics Committees, GCP certificates acquired online are generally not recognised.

The head of the clinical trial is responsible for the correspondence with the ethics committee and is responsible for the submission of the study documents or obtains advice from the ethics committee. However, the overall responsibility for the clinical trial does not lie with the LKP, but with the sponsor of the trial.

On the initiative of the Federal Ministry of Health, a consensus conference with the participation of interested associations of the medical profession and the pharmaceutical industry on April 25, 1997 developed the following requirements profile for the head of the clinical trial:

The LKP has the overall medical responsibility for the study and decides on medical justifiability, start and continuation of the study or its termination.

He is responsible for the legally compliant conduct of the study, including the weighing of benefits and risks, implementation of the study plan, reporting to the authorities and obtaining the ethics vote, communicating the results and submitting a final medical opinion to the sponsor

The clinical trial manager must demonstrate legal and ethical principles, in particular knowledge of AMP, MPG, ISO 14155, GCP and other guidelines.

The clinical trial manager must submit documents such as curriculum vitae, proof of qualifications and certificates (e.g. study director course, GCP certificate, biometric training, etc.) to the ethics committees before the study starts.