Before we dive into the details of Clinical Trials, let us understand the FDA Drug Approval Process.
The steps involved in Drug Approval process is detailed in below two diagrams.
Continued...
Next: ICH-GCP Principles
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Author's Note: The author is a business system analyst primarily analyze clinical trials data. From the knowledge he gained f...
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What is Tables, Listings and Figures? TLFs (Tables, Listings, and Figures) are outputs that are generated from clinical trial data to summar...
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What is a Clinical Protocol Document? A Clinical trial is conducted according to a plan (a protocol) or an action plan. The protocol demonst...
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