Good Clinical Practice

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. GCP provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are respected and protected [1]. It was finalised in 1996 and became effective in 1997, but was not enforced by law at that time. The Medicines for Human Use (Clinical Trials) Regulations 2004 and the European Union (EU) Directive on Good Clinical Practice changed the world perspective , and compliance with GCP is now a legal obligation in the UK/Europe for all trials involving the investigation of medicinal products.

One

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).

Two

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.

Three

The rights, safety and well-being of the trial subjects are the most important considerations and should prevail over interest of science and society.

Four

The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

Five

Clinical trials should be scientifically sound, and described in clear, detailed protocol.

Six

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.

Seven

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.

Eight

Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

Nine

Freely given informed consent should be obtained from every subject prior to clinical trial participation.

Ten

All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

Eleven

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).

Twelve

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.

Thirteen

Systems with procedures that assure the quality of every aspect of the trial should be implemented.

These principles are self-explanatory and, when summarised, simply mean:
All clinical trials should be conducted in accordance with ethical principles, sound scientific evidence and clear detailed protocols. The benefits of conducting trials should outweigh the risks. The rights, safety and well-being of trial participants are of paramount importance and these should be preserved by obtaining informed consent and maintaining confidentiality. The care must be given by appropriately qualified personnel with adequate experience. Records should be easily accessible and retrievable for accurate reporting, verification and interpretation. Investigational products should be manufactured according to Good Manufacturing Practice.
The importance of GCP lies in the question ‘why’ and ‘how’ GCP trials came about. To know the answer to this, we have to look to the historical background that led to the formulation of GCP guidelines in the United States and Europe and also to the formation of the ICH. The events that led up to the culmination of the ICH-GCP guidelines brought forth public awareness that there was a need to control and regulate clinical trials dealing with drugs and human subjects. The violation of human rights played a large role and that is why the Declaration of Helsinki and The Nuremberg Code remain as the framework of the present guidelines. The ICH-GCP guidelines are therefore considered the ‘bible’ of clinical trials, and have become a global law which safeguards humanity as we know it today.