The Importance of Good Clinical Practice Training
By: K Si | Posted: 18th May 2009
Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.
Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds.
Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates.
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 organisations, 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, a major 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.
The online GCP Training is aimed at anyone requiring a thorough understanding of the key areas critical to ICH Good Clinical Practice and is also suitable for those looking for a refresher course to update previous GCP training.
Infonetica's GCP training course has been accredited for 9 Continuing Professional Development credits by the Faculty of Pharmaceutical Medicine.
The ICH-GCP guidelines are considered the ‘bible' of clinical trials, and have become a global law which safeguards humanity as we know it today. Everyone involved in clinical research or clinical trials should be trained in good clinical practice. Guidelines on good clinical practice should be followed and, above all, trust between research subjects and investigators should always be upheld and respected.
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Tags: refresher course, quality standard, research institutes, human subjects, roles and responsibilities, training provider, international quality