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Research and Development

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Good Clinical Practice (GCP)

GCP is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting research that involves human participation.

Compliance provides public assurance that the rights, safety and wellbeing of participants are respected and protected, and that the data generated are credible and accurate.

Compliance with GCP is a legal obligation in Europe for all trials of investigational medicinal products.

Comprising 13 core principles, GCP applies to all clinical investigations that can affect the safety and wellbeing of human participants, particularly Clinical Trials of Investigational Medicinal Products.

GCP core principles

  1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
  2. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
  3. The rights, safety and wellbeing of the trial subjects are the most important considerations and should prevail over interests of science and society.
  4. The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
  5. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
  6. A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
  7. The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
  8. Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s).
  9. Freely given informed consent should be obtained from every subject prior to clinical trial participation.
  10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
  11. The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
  12. Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
  13. Systems with procedures that assure the quality of every aspect of the trial should be implemented.

Please refer to ICH Good Clinical Practice Guidelines at the link below.