Clinical Trials (GCP)

GCP Compliance (Clinical Trials)

Good Clinical Practice: Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible (as per Article 1.2 of 2001/20/EC )

Clinical trials are tightly regulated throughout the world.  It’s important to understand the provenance of these regulations i.e., what is the history behind the regulations, what caused them to be implemented?  By doing this we can understand what the regulations and guidelines are trying to achieve and therefore comply with the regulatory requirements.

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