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GCP |
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There are many excellent books covering this subject, but before drug and device companies and contract research organizations (companies drug and device firms hire to perform clinical trials for them) will call on you to perform clinical trials, they need to know that you have a basic understanding of good clinical practice (GCP). The FDA Guidelines for Good Clinical Practice Section 8 sets out "Essential Documents for the Conduct of a Clinical Trial. There is little on quality assurance and regulation, such as the investigational new drug application process and current good manufacturing practice, although good clinical practice is mentioned. |
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