Clinical Trial Questions: FDA’s Answers

Clinical Trials Advisor
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The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but those documents can’t answer every question you may have. Fortunately, the agency offers another resource—the staff of its Office of Good Clinical Practices (OGCP). Every day, OGCP fields questions from investigators, sponsors, IRBs and other interested parties. Here are FDA’s answers to a couple of those questions.

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