Good Clinical Practice

Good Clinical Practice

International Council for Harmonization (ICH), in its guideline ICH E6 (R2) defines Good Clinical Practice (GCP) as ‘an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.’

The WHO and ICH GCP codes were first issued in 1995 and 1996 respectively (see Table 1 [Ethics and IRB applications]). However, it is important to appreciate that these codes have subsequently evolved in response to developments in the field of medical ethics.

The ICH-GCP guideline was developed with reference to clinical practice in the European Union, Japan, USA, Australia, Canada and the Nordic countries. It now provides a unified standard and facilitates the mutual acceptance of clinical data by the regulatory authorities in differing jurisdictions. Compliance with ICH-GCP is now a legal obligation in many countries. Some countries have modified their own GCP guidelines according to the ICH-GCP.

The principles of ICH-GCP:

  1. Clinical trials should be conducted in accordance with 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 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 well-being of the trial participants are the most important considerations and should prevail over the interest 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/ favorable opinion.
  7. The medical care given to, and medical decisions made on behalf of participants 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 participant 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 participants 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. Systems with procedures that assure the quality of every aspect of the trial should be implemented.
  13. Systems with procedures that assure the quality of every aspect of the trial should be implemented.

These core principles can be summarised as follows: All clinical trials should be conducted in accordance with ethical principles, after establishing sound scientific evidence that the benefits expected of the trial clearly outweigh any potential risks. The rights, safety and wellbeing of trial participants are of prime importance. Informed consent and maintenance of confidentiality are mandatory. The study must be conducted by appropriately qualified personnel with sufficient experience. Detailed study protocols should be defined by the researchers and approved by the Institutional Review Boards (IRBs). Records should be properly maintained, easily accessible and retrievable. Investigational products should be manufactured according to Good Manufacturing Practice.

There is little material difference between WHO-GCP and ICH-GCP, both were written and published in parallel. ICH-GCP is a harmonised guideline, for adoption as a regulatory standard in the ICH countries. WHO-GCP is an informative tool for less experienced users, including regulatory agencies in countries where there is no other guideline. Researchers should also check for a local GCP guideline if conducting research outside an ICH country.