The Importance of Good Clinical Practice Training

Good Clinical Practice is an international quality standard provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (or ICH). The latter is an international body, whose defined standards can be used by governments to transpose into regulations for clinical trials, involving human subjects.

Since 1995, ICH-GCP guidelines have become a global factor in clinical research and have solidified their impact in traditional clinical trial hubs, such as Japan, North America, and The EU. At the same time, their importance is growing perennially in developing clinical market regions.

Good Clinical Practice Guidelines include standards on how clinical trials to be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors (also known as Clinical Research Associates).

On the practical side, they are to be followed universally, in order to globally improve safety, efficiency, and communication between all parties involved within clinical research and trials, i.e., to benefit all of humanity. Therefore, Good Clinical Practice guidelines include details, such as protection of human rights as a subject in clinical trials. They also provide assurance of the safety and efficacy of the newly developed compounds.

As prescribed by the international standards and requirements, a basic understanding of Good Clinical Practice is pre-requisite for anyone carrying out, or involved with, clinical research and clinical trials. The training is therefore relevant to:

-          Investigators from NHS organizations, university hospitals, pharmaceutical companies and research institutes

-          Research Nurses

-          R&D staff involved with approving and monitoring clinical trials

-          Members of ethics committees

-          Clinical trials support staff (e.g. CRO staff)

Infonetica, the online ICH-GCP training provider, has recently updated its ICH-GCP online training, which delivers an up-to-date and comprehensive guide to the basic principles of ICH-Good Clinical Practice and covers all the new changes/amendments proposed in the EU Directive 2005/28/EC. Written by Dr Isaac John, Assistant Director of Research and Development at Ashford and St Peter's Hospitals NHS Trust, the course is endorsed by Royal Holloway, University of London, and delivers 9 Continual Professional Development points.

Infonetica’s online GCP training is suitable for both first-timers, as well as those looking for a refresher course to update previous GCP training.