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What information should an independent, central IRB obtain about the site?

April 26, 2017independent IRB obtain site

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What information should an independent, central IRB obtain about the site?

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Information that is relevant to an independent, central IRB about a research site includes the education and training of all study personnel, the site’s history and experience in conducting clinical research, federal agency inspection reports, type of demographics the site will encounter, and safeguards for vulnerable subjects. Please refer to the Research Site Submission Form for complete information required by the IRB. In certain situations, the Board may request that a site visit be conducted.