Good Clinical Practice for Device Trials
Posted 01 January 2009 | By
The term Good Clinical Practice (GCP) refers to a recognized set of ethical and scientific principles for designing, recording and reporting clinical trials to ensure that the patients' rights, safety and well being are protected and that clinical trial data are credible. For medicinal products, these principles are laid out in a unified standard for the US, Europe and Japan, published 12 years ago by the International Conference on Harmonisation (ICH).1 The ICH-GCP document is embraced by the US Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research; and it is implemented in the regulations for the conduct of clinical trials in the European Union (EU), specifically the Clinical Trial Directive (Directive 2001/20/EC) and the GCP Directive (2005/28/EC). For the pharmaceutical industry, such harmonization of clinical research requirements obviates the need to duplicate the testing carried out during the research and development phase. It also eliminates unnecessary delay in the global availability of new medicines while maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.