What does "sponsor" mean in clinical trials?

The sponsor plays an important role in clinical trials in accordance with the MDR 2017 and the Medical Device Law Implementation Act. The sponsor is the organization or individual who bears the main responsibility for the initiation, management and financing of the clinical trial. This is usually the manufacturer of the medical device. Here are some important aspects that illustrate the importance of the sponsor:

1. Financing:

- The sponsor provides the financial resources for planning and conducting the clinical trial.

2. Initiation:

- The sponsor initiates the clinical trial and is responsible for selecting the trial centers.

3. Responsibility:

- The sponsor bears overall responsibility for the study and ensures that all legal and ethical standards are met.

4. Documentation:

- The sponsor ensures comprehensive documentation of all aspects of the clinical trial.

5. Risk management:

- The sponsor is responsible for identifying risks and taking appropriate measures to minimize these risks.

6.study planning:

- The sponsor is significantly involved in the planning of the clinical trial and contributes to the development of the study protocol.

7. data security:

- The sponsor guarantees the security and integrity of the data collected during the study.

8. contact with authorities:

- The sponsor is the contact person for the responsible authorities and ensures that the study meets the legal requirements.

The sponsor plays a critical role in ensuring the quality and integrity of clinical trials and contributes to the safety of participants and the validity of trial results.