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How to Register Your Study - ClinicalTrials.gov
https://classic.clinicaltrials.gov:443/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:443/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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ClinicalTrials.gov Final Rule (42 CFR Part 11) Information
https://prsinfo.clinicaltrials.gov:443/
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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Frequently Asked Questions about Clinicaltrials.gov Registration …
https://www.nimh.nih.gov:443/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:443/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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ClinicalTrials.gov Registration and Reporting | Research Roadmap
https://researchroadmap.mssm.edu:443/investigator/clinicaltrials-gov-requirements/
WEBJan 16, 2024 · All records must be reviewed and if applicable, updated every 12 months. In general, clinical trial registration information submitted to ClinicalTrials.gov must be updated not less than once every 12 months. Some data elements may be required to be updated more rapidly, generally 15-30 days.
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Submit Studies - ClinicalTrials.gov
https://classic.clinicaltrials.gov:443/ct2/manage-recs
WEBThe ClinicalTrials.gov Protocol Registration and Results System (PRS) is a Web-based data entry system used to register a clinical study or submit results information for a registered study. You must have an account in order to Login to ClinicalTrials.gov PRS.
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Register with ClinicalTrials.gov
https://www.niams.nih.gov:443/grants-funding/conducting-clinical-research/register-trials-gov
WEBAug 2, 2019 · To register your clinical trial: Check to see whether your organization already has a PRS organization account. . Apply for a PRS account. See how to apply for an account. on ClinicalTrials.gov. Logon to PRS on the PRS Login Page. . Enter the required and optional data elements. Preview, inspect, and submit the record.
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Why Should I Register and Submit Results? - ClinicalTrials.gov
https://classic.clinicaltrials.gov:443/ct2/manage-recs/background
WEBView Frequently Asked Questions (FAQs) about the Final Rule (42 CFR Part 11). Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) requires responsible parties to register clinical trials and submit summary results to ClinicalTrials.gov.
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Policy and Regulation on ClinicalTrials.gov Registration and …
https://grants.nih.gov:443/policy/clinical-trials/reporting/understanding.htm
WEBThe Final Rule describes requirements for registering and submitting summary results information for certain clinical trials to ClinicalTrials.gov. The changes made to FDAAA 801 by the Final Rule are available as a summary and table (PDF) . NIH's Clinical Trials Dissemination Policy.
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