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How to Register Your Study - ClinicalTrials.gov
https://classic.clinicaltrials.gov/ct2/manage-recs/how-register
WEBLearn about submission requirements. ClinicalTrials.gov allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes and that conform to: Any applicable human subject or ethics review regulations (or equivalent) Any applicable regulations of the national or regional health authority (or equivalent)
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ClinicalTrials.gov Registration & Reporting Requirements
https://research.oregonstate.edu/irb/clinicaltrialsgov-registration-reporting-requirements
WEBIn a Nutshell Studies must be registered with ClinicalTrials.gov if: they involve drugs, devices, or biologics that are regulated by the Food and Drug Administration (FDA), OR they are federally funded and meet the definition of a clinical trial, OR there is a plan to publish the results in a medical journal AND the study meets the ...
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Frequently Asked Questions about Clinicaltrials.gov Registration …
https://www.nimh.nih.gov/funding/clinical-research/researchers/frequently-asked-questions-about-clinicaltrialsgov-registration-and-results-submission-for-nimh-funded-clinical-trials
WEBEffective January 18, 2017, the NIH Policy on the Dissemination of NIH-funded Clinical Trials establishes the expectation for Clinicaltrials.gov registration of all NIH-funded clinical trials, funded in whole or in part by NIH, regardless of study phase, type of intervention, or whether the trial is subject to FDAAA.
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NIH Requirements for Clinical Trials Registration and …
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
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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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Requirements for Registering & Reporting NIH-funded Clinical Trials …
https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
WEBOct 24, 2017 · All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information" for competing applications and contract proposals submitted on or after January 18, 2017 .
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Register with ClinicalTrials.gov
https://www.niams.nih.gov/grants-funding/conducting-clinical-research/register-trials-gov
WEBAug 2, 2019 · The Food and Drug Administration Amendments Act of 2007 (also called FDAAA) requires that clinical trial sponsors register and report results for certain clinical trials of drugs, biologics, and devices that are subject to FDA regulation ( see Public Law 110-85, Title VIII ).
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Why Should I Register and Submit Results? - ClinicalTrials.gov
https://classic.clinicaltrials.gov/ct2/manage-recs/background
WEBThe Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments A...
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Submit Studies - ClinicalTrials.gov
https://classic.clinicaltrials.gov/ct2/manage-recs
WEBNew to registering studies? See For Study Record Managers. Why Should I Register and Submit Results? Learn about the purpose of study registration and results submission. Includes an overview of applicable laws and policies. FDAAA 801 and the Final Rule.
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Registration at ClinicalTrials.gov: As required by Public Law …
https://prsinfo.clinicaltrials.gov/s801-fact-sheet.pdf
WEBGENERAL REQUIREMENTS FOR REGISTRATION. A. Clinical Trials That Must be Registered at ClinicalTrials.gov (“Applicable Clinical Trials”) Trials of Drugs and Biologics: controlled clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation [1]
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