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What is an Applicable Clinical Trial (ACT…
https://research.cuanschutz.edu/crs/clinical-research-support/clinical-research-administration/clinicaltrials.gov-support/tips-of-the-week-archive/tip-of-the-week-april-2-2020/what-is-an-applicable-clinical-trial-(act)
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Checklist for Evaluating Whether a Clinical Trial or Study is an
https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf
File Size: 944KB Page Count: 9
File Size: 944KB
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ClinicalTrials.gov
https://clinicaltrials.gov/
WEB8600 Rockville Pike, Bethesda, MD 20894. Go to the classic website. ClinicalTrials.gov. An official website of the U.S. Department of Health and Human Services, National …
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Home - ClinicalTrials.gov
https://classic.clinicaltrials.gov/
WEBClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Explore 492,685 …
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Identifying an “Applicable Clinical Trial” under FDAAA
https://grants.nih.gov/ClinicalTrials_fdaaa/docs/Flow_chart-ACT_only.pdf
WEBYes. Review the following criteria to determine if the applicable clinical trial (ACT) needs to be registered under FDAAA: If the trial was initiated after 9/27/2007 ... If the trial was … File Size: 391KB Page Count: 1
File Size: 391KB
Page Count: 1
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ClinicalTrials.gov Final Rule (42 CFR Part 11) Information
https://prsinfo.clinicaltrials.gov/
WEBChanges from Current Practice Described in the Final Rule: Summarizes changes in ClinicalTrials.gov and PRS requirements and practices for applicable clinical trials …
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ClinicalTrials.gov: Applicable Clinical Trials | Clinical Research
https://hub.ucsf.edu/clinicaltrialsgov-applicable-clinical-trials
WEBOct 15, 2020 · ClinicalTrials.gov: Applicable Clinical Trials. Last revised: 10/15/2020. Definition of a Clinical Trial. The World Health Organization (WHO) defines a clinical trial …
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FDA's Role: ClinicalTrials.gov Information | FDA - U.S. Food and …
https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/fdas-role-clinicaltrialsgov-information
WEBMay 26, 2023 · The Food and Drug Administration Amendments Act of 2007 () requires that the “Responsible Party” for certain clinical trials register with, and submit the results …
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