What is the role of a lead investigator in a clinical trial?

The LCP has overall medical responsibility for the study with at least two years of experience in clinical trials or performance studies and corresponding further qualifications (for Germany §30 MPDG). He or she is responsible for deciding on the medical justifiability, the start, continuation and termination of the study in the event of unacceptable risks to subjects and patients. He or she is responsible for conducting the study in accordance with the protocol, reporting the results and submitting a final assessment to the sponsor.

In a clinical trial in accordance with the MDR 2017 and the Medical Device Law Implementation Act, the head of the clinical trial (LKP) plays a decisive role. This person is responsible for the organization and conduct of the clinical trial. Here are some important aspects of a LCP:

1. Study planning and design:

- The LCP is significantly involved in the planning and design of the clinical trial, including the definition of study objectives and protocols.

2. Ethics committee and contacts with authorities:

- He/she interacts with ethics committees and competent authorities to obtain approvals and fulfill regulatory requirements.

3. Study coordination:

- The LCP monitors the clinical trial process, coordinates the study team and ensures that the study is conducted in accordance with the study protocol.

4. Subject protection:

- The focus is on the safety of the participants, and the LCP ensures that ethical and legal aspects of subject protection are observed.

5. Data management:

- The LKP contributes to correct data collection and management and ensures that the integrity of the study data is maintained.

Overall, the LCP plays a central role in ensuring that clinical trials are conducted in accordance with legal requirements and ethical standards and deliver meaningful results.