ClinicalTrials.gov registration is required for all federally sponsored clinical trials and studies that meet the FDA definition of an “Applicable Clinical Trial” (ACT), regardless of funding. ClinicalTrials.gov registration requirements expanded after Congress passed the FDA Amendments Act of 2007 (FDAAA). Section 801 of FDAAA (FDAAA 801). Requiring more types of trials to be registered and additional registration information to be submitted. In September 2016, HHS issued the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), clarifying and expanding the information submission requirements of FDAAA 801. Information on ClinicalTrials.gov is provided and updated by the sponsors, principal investigators, and other designated study team members through the Protocol Registration and Results System (PRS) at register.clinicaltrials.gov.
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Resources |
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Account, Protocol Registration and Record Maintenance |
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Result Reporting |
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National Institutes of Health (NIH) |
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International Committee of Medical Journal Editors (ICMJE) |
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ICF Language, ICF Upload – Common Rule |
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Education and Training |
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Links and Supplementary Resources |
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PI Off Boarding |
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Civil Money Penalties |
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University of Utah Clinical Trials.Gov Contacts |