Good Clinical Practice (GCP) guidelines for clinical trials

Good Clinical Practice (GCP) is an international scientific quality standard for the design, performance, conduct, auditing, monitoring, recording, and reporting of clinical trials. GCP is a document that helps regulate clinical trials and is published by the international council of Harmonization (ICH). ICH-GCP guidelines are used in clinical trials across the globe with the primary aim of protecting and preserving human rights. Moreover, it also serves to protect the rights, confidentiality, and integrity of trial subjects. The primary goal of clinical research is to find the new well-defined standards of therapy, limited population to benefit the larger population. Clinical trials are the mechanism to prove new therapies are safe and effective. By following GCP guidelines, the accurate, verifiable, and reproducible data can be generated from the clinical trials, all of which are necessary to advance scientific knowledge. Conducting research according the GCP guidelines is also the law. Additionally, it is also significant to understand the background of the formation of the ICH-GCP guidelines as it explains the reasons and the need for doing so. GCP also offers public assurance that the safety, rights, well-being, and confidentiality of trial participants are protected.

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There are 13 principles of ICH-GCP and they are as follows:

  1. Clinical trials must be always performed in accordance with the ethical principles which should be considered to have the origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement.
  2. Prior to the trial initiation, foreseeable inconveniences and risks should be weighed against the predicted benefit for the individual trial subject and society. Trial initiation and continuation should be done only if the predicted benefits justify the risks.
  3. The safety rights and well-being of the trial subjects are the primarily significant considerations and should overcome over interest of science and society.
  4. The existing clinical and non-clinical information on an investigational product should be adequate and satisfactory to support the proposed clinical trial.
  5. Clinical trials must be scientifically described in clear, detailed protocol, and should be sound.
  6. A clinical trial must be always conducted in the compliance with the protocol, received prior independent ethics committee (IEC) approval/institutional review board (IRB)/favorable opinion.
  7. The medical care and medical decisions made must be always be the concerned of a qualified physician or, when appropriate, of a qualified dentist.
  8. Every individual is involved in directing a trial that must be qualified by training, education, and experience to perform the respective task.
  9. Freely provided consent must be obtained from every subject prior to participation of any clinical trial.
  10. All the collected data should be handled, recorded, and stored in a proper way that allows its accurate interpretation, reporting, and verification.
  11. The confidentiality of the collected records that helps to identify subjects that must be protected, respecting the privacy and confidentiality rules in accordance with the need of applicable regulatory.
  12. Investigational products should be produced, stored and handled in accordance with applicability of Good Manufacturing Practice (GMP). Furthermore, they must be used in accordance with the approved protocol.
  13. Systems in accordance with procedures assures the quality of each and every aspect of the clinical trial that should be executed

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