GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies. Just as with every other aspect of FDA compliance, the regulations state that: Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
The Four Goals of GCP
Clinical trials are sensitive research processes that can, if handled wrongly, create legal liabilities and ethical issues for organizations. Therefore, companies that need to research the effect and efficacy of newly developed pharmaceuticals or medical treatment on human subjects need to have FDA GCP Training.
FDA GCP Training Ensures That:
The Six Regulations Covering FDA GCP Training
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