Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct and record of research involving humans.

All of our staff involved in the conduct of a clinical trial of an investigational medicinal product (CTIMP) must receive initial and regular update training in GCP. This is a legal requirement under the UK legislation on clinical trials.

You need to attend GCP training if you are a:

• Principal Investigator/Co-investigator
• Research Nurse
• Trial Coordinator
• Trial Pharmacist
• Member of a laboratory involved in data analysis related to the trial

Comprised of 13 core principals, GCP applies to all clinical investigations that could affect the safety and well-being of human participants (in particular, clinical trials of medicinal products).

GCP was developed by the regulatory authorities of the EU, Japan and US in a steering group termed the Tripartite International Conference on Harmonisation (ICH) and provide international assurance that:

• data and reported results of clinical investigations are credible and accurate
• rights, safety and confidentiality of participants in clinical research are respected and protected

It was finalised in 1996 and became effective in 1997. When first expounded, it was internationally recognised as best practice, but was not enforceable by law.

However, with the advent of the Medicines for Human Use (Clinical Trials) Regulations 2004 and the recent EU directive on Good Clinical Practice, compliance with GCP is now a legal obligation in the UK/Europe for all trials of investigational medicinal products.

GCP – 13 PRINCIPLES

1. Clinical trials should be conducted in accordance with the ethical principles that have their original 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 weighted 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 well-being 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.

GCP COURSES

Our one-day GCP course has been accredited by the Royal College of Physicians, London at six CPD points and is open to all Trust staff irrespective of which organisation is sponsoring the trial. A certificate of attendance is issued after completion of the course. GCP certificates are subject to audit and inspection by the regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA).

REFRESHER COURSES

If you attended a GCP course prior to 2009, you need to attend a refresher course to update your GCP Training and to gain knowledge of the amendments to the UK legislation of the Medicines for Human Use (Clinical Trials) Regulations 2004. If your GCP training certificate is now more than two years old, we invite you to attend our GCP refresher course, which lasts approximately half a day, followed by a half hour question and answer session at the end. The course is accredited with two CPD points form the Royal College of Physicians and certificates will be handed out at the end.