Good clinical practice - what is it?

The principles of Good Clinical Practice (GCP) form the basis for ethical and scientifically sound clinical studies for medical devices.

They include

1. Ethical principles: Studies must be conducted in accordance with the Declaration of Helsinki.
2. Risk-benefit assessment: Risks must be weighed against the expected benefits before the study begins.
3. Prioritisation of participant rights: The safety and well-being of the study participants have top priority.
4. Scientific soundness: Studies must be based on sound science.
5. Detailed protocol: A clear and detailed clinical investigation plan (CIP) is required.
6. Approval procedure: The CIP must be approved by ethics committees and, if necessary, authorities.
7. Qualified personnel: All participants must be appropriately qualified for their tasks.
8. Informed consent: Participants must be informed and consent voluntarily before the start of the study.
9. Data protection and security: All study data must be treated securely and confidentially.
10. Quality assurance: Quality assurance systems must be implemented for all aspects of the study.

These principles ensure the protection of study participants and the reliability of study results.