Good clinical practice - what is that?

The principles of Good Clinical Practice (GCP) form the basis for ethical and scientifically sound clinical investigations for medical devices (medical device clinical trial) . They are laid down in the ISO14155.

Basically, they include

1. Ethical principles: Clinical 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 management: Quality management systems must be implemented for all aspects of the study.

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

Benefit from our many years of experience in designing and carrying out clinical studies /investigations and contact us for an initial consultation.

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