WebIf a clinical trial is not an applicable clinical trial (ACT) at study initiation because it is conducted entirely outside the United States, but the trial subsequently opens a U.S. site, am I required to register the trial? If my study is an applicable clinical trial (ACT), am I required to register? WebRegistration on ClinicalTrials.gov is . not required. Study involves human participants? YES NO . Participants are prospectively assigned to an . intervention? (not observational) YES . Intervention evaluates a health-related, biomedical, or behavioral outcome? YES NO . Your study is not a clinical trial. Registration on ClinicalTrials.gov is ...
Registering with ClinicalTrials.gov Guidance Portal
WebWe're building a better ClinicalTrials.gov. Check it out and tell us what you think! Hide glossary Glossary. ... Submit Studies to ClinicalTrials.gov PRS; Why Should I Register and Submit Results? FDAAA 801 and the Final Rule; How to Apply for a PRS Account; How to Register Your Study; WebRegistering an Investigator-Initiated Clinical Trial Overview ClinicalTrials.gov is a web-based registry maintained by the National Library of Medicine which was originally created in response to the 1997 FDA Modernization Act (FDAMA) and has been publically available since February 2000. does heparin cause low rbc
ClinicalTrials.gov Final Rule (42 CFR Part 11) Information
WebEffective January 18, 2024, 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. This policy applies to ... WebA ClinicalTrials.gov staff member will review the study record after it is released (submitted) and before it is published on ClinicalTrials.gov. This review will focus on apparent validity (when possible), meaningful entries, logic and internal consistency, and … Why Do I Need to Register My Trial and Submit Results to ClinicalTrials.gov? … Protocol Registration Data Element Definitions - How to Register Your Study … WebApr 12, 2024 · This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. ... focusing on the design of efficient clinical trial protocols, tools for identifying and tracking ... does heparin contain pork products