clinicaltrials.gov posting requirements | ClinicalTrials.gov Final Rul

Keyword	CPC	PCC	Volume	Score	Length of keyword
clinicaltrials.gov posting requirements	0.88	0.3	3656	96	39
clinicaltrials.gov	1.66	0.3	5778	62	18
posting	1.8	0.3	784	45	7
requirements	1.89	0.1	8340	81	12

Keyword	CPC	PCC	Volume	Score
clinicaltrials.gov posting requirements	1.42	0.9	5924	39

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ClinicalTrials.gov Final Rule (42 CFR Part 11) Information
clinicaltrials.gov

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
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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How to Submit Your Results - ClinicalTrials.gov
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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Submit Studies - ClinicalTrials.gov
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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Requirements for Registering & Reporting NIH-funded Clinical Trials …
nih.gov

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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ClinicalTrials.gov – Who, How, Consent Form Posting, Legal Requirements
bu.edu

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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Overview of Clinicaltrials.gov Result Posting Requirement
cornell.edu

https://research.weill.cornell.edu/sites/default/files/4_-_ct.gov_results_gg.pdf

WEBDec 11, 2017 · Why Post Research Results? Allows access for patients to innovative clinical trials. Fulfills ethical obligation to human subjects. Inform future research through evidence-based. Mitigates information bias and duplication of trials. Posting Requirements for ClinicalTrials.gov. *New ICMJE Requirement: Data Sharing Statement.

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ClinicalTrials.gov Registration & Reporting Requirements
oregonstate.edu

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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Why Should I Register and Submit Results? - ClinicalTrials.gov
clinicaltrials.gov

https://classic.clinicaltrials.gov/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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FDA's Role: ClinicalTrials.gov Information | FDA - U.S. Food and …
fda.gov

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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