Good Clinical Practice
Almost every aspect of pharmaceutical medicine is subject to regulation and for many years it has been a requirement of regulatory authorities that clinical trials performed to support licensing of new medicines be conducted in compliance with a set of standards known as Good Clinical Practice (GCP). Therefore pharmaceutical physicians, clinical research scientists, research nurses and others employed within the industry are required to have a good working knowledge of GCP. Most pharmaceutical companies provide training courses for their personnel either in-house or externally. However, for the most part training has not extended to clinicians, research nurses, technicians and other personnel serving as investigators and support staff involved in the conduct of clinical trials. Furthermore, there has been no qualification in GCP widely recognised as evidence of attaining a satisfactory standard of knowledge. The importance of attaining adequate knowledge of GCP extends beyond the investigation of potential new pharmaceuticals since an EU Clinical Trials Directive stipulates that from 2004 all clinical trials on human subjects involving medicinal products in the European Union, irrespective of their purpose, must be conducted in compliance with GCP. In the UK the EU Clinical Trials Directive was implemented from 1st May 2004.
There are no specific eligibility criteria to register for the Certificate examination. It is open to all personnel involved in the conduct of clinical trials including research nurses, clinical research scientists and technicians as well as physicians. The examination will be held in the UK but candidates may be from any country. Successful candidates will be awarded the Certificate of GCP. To gain the required standard in the examination, candidates will need to prepare themselves. The 
syllabus includes some suggested reading material and a list of some useful websites, which are by no means exhaustive, are appended. The examination regulations and procedures contain other important information, which candidates should read before submitting an application. In addition to private study, candidates may wish to attend a training course in GCP. The Faculty does not currently have the resources to provide training for the examination but several independent organisations offer courses in GCP.
The next examination will be held in June 2009 (date tbc) at the Royal College of Physicians, London.