What are the 13 principles of GCP?

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There are 12 principles of Clinical trials, as below:

1. Clinical trials must be carried out in accordance with the ethical standards outlined in the Declaration of Helsinki, which are also compliant with good clinical practice (GCP) and any relevant regulatory requirement(s).

2. Clinical trials should be designed and carried out in a way that protects participants' rights, safety, and wellbeing.

3. An essential component of a trial's ethical conduct is informed consent. Participation in clinical trials should be completely voluntary and based on an informed consent process.

  1. An impartial ethics committee (IEC) or institutional review board (IRB) should conduct a dispassionate examination of clinical studies.

  2. Clinical trials should be founded on sound and up-to-date scientific knowledge and methodologies, and scientifically sound for their intended aim.

  3. Clinical trials should be planned and carried out by professionals.

  4. Clinical trial design, execution, and quality assurance should all be considered.

  5. Processes, methods, and approaches used in clinical trials should be proportionate to the risks involved for the participants and the accuracy of the findings.

  6. A protocol that is operationally practical, transparent, and succinct should explain clinical trials.

  7. Clinical trials should produce accurate findings.

  8. Clinical trial roles, duties, and tasks must be understood and properly documented.

  9. Investigational products used in clinical trials should be produced in line with applicable Good Manufacturing Practice (GMP) regulations and handled, delivered, and kept in conformity with the study protocol and the product's specifications.

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