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ClinicalTrials.gov Final Rule (42 CFR Part 11) Information
https://prsinfo.clinicaltrials.gov/
WebThe Final Rule clarifies and expands the requirements for submitting clinical trial registration and results information to ClinicalTrials.gov in accordance with Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801).
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PRS User's Guide - ClinicalTrials.gov
https://prsinfo.clinicaltrials.gov/prs-users-guide.html
WebClinicalTrials.gov requires certain data elements to be entered before the record can be submitted for PRS Review and posting. Optional fields are not required for posting on ClinicalTrials.gov, but may be required to comply with FDAAA 801 or meet the requirements of other organizations (such as medical journals or funding sources).
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Home - ClinicalTrials.gov
https://clinicaltrials.gov/ct2/manage-recs/fdaaa
WebWe would like to show you a description here but the site won’t allow us.
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How to Submit Your Results - ClinicalTrials.gov
https://classic.clinicaltrials.gov/ct2/manage-recs/how-report
WebFor certain clinical trials subject to the requirements of Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801), Responsible Parties must submit scientific and administrative information about the results …
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ClinicalTrials.gov
https://clinicaltrials.gov/policy/reporting-requirements
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 Institutes of Health, National Library of Medicine, and National Center for Biotechnology Information.
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FDA Takes Action For Failure to Submit Required Clinical Trial Results
https://www.fda.gov/news-events/press-announcements/fda-takes-action-failure-submit-required-clinical-trial-results-information-clinicaltrialsgov
WebThe FDA makes determinations about whether responsible parties are complying with legal requirements for submitting information to ClinicalTrials.gov for applicable clinical trials.
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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 · To certify compliance with ClinicalTrials.gov requirements, FDA requires that applicants complete and submit Form FDA 3674 with certain human drug, biological product, and device...
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ClinicalTrials.gov Registration & Reporting Requirements
https://research.oregonstate.edu/irb/clinicaltrialsgov-registration-reporting-requirements
WebClinicalTrials.gov is the result of a federal law requiring that clinical trials be registered to improve public access to information about clinical research, promote public trust in research, and inform future research. In some cases, registration is …
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ClinicalTrials.gov – Who, How, Consent Form Posting, Legal Requirements
https://www.bumc.bu.edu/ohra/clinicaltrials-gov/registration-and-results-reporting-who-and-how/
WebOne of the revisions of the 2018 Common Rule that became effective on January 21, 2019 [45 CFR 46.116 (h)] specifies that a consent form must be posted on a federal website for all clinical trials who receive specific federal funding* and are either (a) approved by an IRB on or after January 21, 2019 or (b) approved earlier but transitioned to R...
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ClinicalTrials.gov PRS
https://prsinfo.clinicaltrials.gov/trainTrainer/202108workshop/requirements/nih_requirements_ct_registration_reporting_annotated_resources.pdf
WebRequirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov: Find resources for understanding and complying with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information and the federal regulations in FDAAA 801 as implemented by 42 CFR Part 11 (the Final Rule). (Source: NIH Grants & …
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