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Must applications to the Phase II Clinical Trials Program of Novel Therapies for Heart, Lung, and Blood Diseases include a protocol and a sample consent?

April 26, 2017applications clinical trials heart ii lung phase program Therapies

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Must applications to the Phase II Clinical Trials Program of Novel Therapies for Heart, Lung, and Blood Diseases include a protocol and a sample consent?

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A5. Yes. An application must include an appropriate data and safety monitoring plan and an appendix that includes the protocol and a sample informed consent.