The Trial Master File What is it? - Drug Information Association
The Trial Master File What is it? - Drug Information Association
The Trial Master File What is it? - Drug Information Association
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TMF – Why <strong>is</strong> <strong>it</strong> so important?<br />
• Required to allow reconstruction of the<br />
conduct of a trial.<br />
– Allow regulators and the public to have confidence<br />
that:<br />
• Patient/Subject rights were protected protected,<br />
• Good Clinical Practices were followed, and<br />
• Data collected, analyzed, and reported as part of a<br />
clinical trial <strong>is</strong> reproducible and of high qual<strong>it</strong>y<br />
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