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Checklist for Evaluating Whether a Clinical Trial or Study ...

Is a service of the National Institutes of Health. ACT Checklist 1 27 June 2018 Checklist for Evaluating Whether a Clinical Trial or Study is an applicable Clinical Trial (ACT) Under 42 CFR (b) for Clinical Trials Initiated on or After January 18, 20171 (NOT FOR SUBMISSION2) Instructions: Answer the following questions to evaluate Whether the Study is an applicable Clinical Trial (ACT). Use the accompanying "Elaboration" for additional information to help answer the questions. Question Yes No the Study interventional (a Clinical Trial )? Study Type data element is Interventional ANY of the following apply (is the answer Yes to at least one of the followingsub-questions: 2a, 2b, OR 2c)? at least one Study facility located in the United States or a territory?Facility Location Country data element is United States, American Samoa, Guam, Northern Mariana Islands, Puerto Rico, Virgin Islands, or the Study conducted under a FDA Investigational New Drug application (IND)or Investigational Device Exemption (IDE)?

Jun 27, 2018 · The “Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT)” (or “ACT Checklist”) and this elaboration is intended to assist users in evaluating whether a clinical trial or study is considered to meet the definition of an ACT, as specified in 42 CFR 11.22(b),

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