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Clinical Research Basics
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The GCP is an internationally-accepted ethical and scientific quality standard, which revolves around everything concerning medication trials with human subjects. Complete compliance with these standards assures the public that both the rights and safety of test subjects are maintained, backed up by principles, which found their inauguration with the Declaration of Helsinki.
This ICH GCP Guideline aims to provide a unified standard for the EU, Japan and US in order to maintain mutual acceptance of clinical data by all regulatory authorities for these jurisdictions.
This guideline is especially devise with close consideration of the better clinical practices of the EU, Japan and US, but also including those of Australia, Canada, the Nordic Countries and WHO (World Health Organization).
Whenever clinical data aimed to be submitted to regulatory authorities is generated, this guideline should be followed. These principles might safely be used for other investigations as well, especially when the safety and well-being of humans is considered.