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\nChecklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT) Under 42 CFR 11.22(b) for Clinical Trials Initiated on or After January 18, 20171  \n(NOT FOR SUBMISSION2)  \nInstructions: 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.  \n\n| Question Yes No |  |  |  |  |  |  |\n| --- | --- | --- | --- | --- | --- | --- |\n|  |  |  |  |  |  |  |\n| 1. Is the study interventional (a clinical trial)?\u003Cbr>Study Type data element is “Interventional” |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |\n| 2. Do ANY of the following apply (is the answer “Yes” to at least one of the following sub-questions: 2a, 2b, OR 2c)?\u003Cbr>a. Is at least one study facility located in the United States or a U.S. territory?\u003Cbr>Facility Location – Country data element is “United States,” “American Samoa,”“Guam,” “Northern Mariana Islands,” “Puerto Rico,” “U.S. Virgin Islands,” or other\u003Cbr>U.S. territory.\u003Cbr>\u003Cbr>b. Is the study conducted under a U.S. FDA Investigational New Drug application (IND) or Investigational Device Exemption (IDE)?\u003Cbr>U.S. Food and Drug Administration IND or IDE Number data element is “Yes.”\u003Cbr>c. Does the study involve a drug, biological, or device product that is manufactured in and exported from the U.S. (or a U.S. territory) for study in another country?\u003Cbr>[Product Manufactured in and Exported from the U.S.](Product Manufactured in and Exported from the U.S. data)[ data](Product Manufactured in and Exported from the U.S. data) element is “Yes.” |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |\n| 3. Does the study evaluate at least one drug, biological, or device product regulated by the United States Food and Drug Administration (U.S. FDA)?\u003Cbr>Studies a U.S. FDA-regulated Device Product data element is “Yes” and/or\u003Cbr>Studies a U.S. FDA-regulated Drug Product data element is “Yes.” |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |\n| 4. Is the study other than a Phase 1 trial of a drug and/or biological product or is the study other than a device feasibility study?\u003Cbr>For drug product trials, Study Phase data element is NOT “Phase 1” and\u003Cbr>for device product trials, Primary Purpose is NOT “Device Feasibility.”\u003Cbr>|  |  |  |  |  |  |\n\nIf “Yes” is answered to all 4 questions, and the study was initiated on or after January 18, 2017, the trial would meet the definition of an ACT that is required to be registered under 42 CFR 11.22.  \n1 All pediatric postmarket surveillance studies of a device product as required by U.S. FDA under section 522 of the FD&C Act and for which FDA approved the plan on or after January 18, 2017 meet the definition of an ACT in 42 CFR Part 11 . 22(b) and are subject to the final rule requirements.  \n2 The outcome generated by the checklist tool will not be retained by the Agency and will not be binding on either the user or any Government agency in any future actions.  \nElaboration: Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT) Under 42 CFR 11.22(b) for Clinical Trials Initiated on or After January 18, 2017  \nThe final rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) specifies requirements for submitting clinical trial information [to ClinicalTrials.gov. The](to ClinicalTrials.gov. 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), and is subject to “expanded” registration requirements under the final rule.  \nGeneral Considerations  \n1. Definition of ACT. Under the Final Rule, which implements Section 801 of the Food and Drug A","cbCailPTc3vBPFJi","https://ap.wps.com/l/cbCailPTc3vBPFJi","pdf",967279,"English","# Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT)\n## Evaluation questions (1–4)\n## General Considerations\n### Definition of ACT\n### Determination of ACT","[{\"question\":\"What is the purpose of the ACT checklist?\",\"answer\":\"The checklist helps determine whether a clinical trial or study qualifies as an Applicable Clinical Trial (ACT) under 42 CFR 11.22(b) for trials initiated on or after January 18, 2017.\"},{\"question\":\"Which criteria does the checklist use to decide if a study is an ACT?\",\"answer\":\"It asks whether the study is interventional, whether U.S. facility/FDA IND-IDE/product-export conditions apply, whether at least one U.S. FDA-regulated drug/biologic/device is evaluated, and whether the study is not a Phase 1 trial (for drugs/biologics) or not a device feasibility study.\"},{\"question\":\"Does a positive checklist result guarantee future reporting outcomes?\",\"answer\":\"No. The document states that the outcome generated by the checklist tool is not retained by the Agency and is not binding on the user or any government agency in future actions.\"}]","ACT_Checklist - Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT) | PDF",1790199813,23]