Who Should use ClinicalTrials.gov, and What is ClinicalTrials.gov?
ClinicalTrials.gov is a registry of federally and privately funded clinical trials conducted in the United States and around the world. Managed by the National Library of Medicine (NLM) at the National Institute of Health (NIH), ClinicalTrials.gov aims to increase transparency and improve public awareness of research. It is a public information resource intended for a wide audience, including individuals with serious or life-threatening diseases or conditions, members of the public, health care providers, and researchers.
Why Should You use ClinicalTrials.gov?
ClinicalTrials.gov launched in 2000 and was created as part of a law that was passed in 1997 (Food and Drug Administration Modernization Act of 1997). This law required the U.S. National Institutes of Health (NIH) to create a database of clinical trials that have an investigational new drug (IND) application to test investigational drugs for serious or life-threatening diseases.
When Should You use ClinicalTrials.gov?
FDAAA and NIH Policy: The Responsible Party (that is, the sponsor or designated PI) must register the trial no later than 21 days after enrollment of the first subject.
ICJME Compliance: The ICJME requires registration before the first subject is enrolled.
How Do I use ClinicalTrials.gov?
For ClinicalTrials.gov registration, click HERE.
For more information on CT.gov registration and reporting results, visit the Research Roadmap here.
ConduITS is supported by NCATS of the NIH’s CTSA Program. Any use of CTSA-supported resources requires citation of grant number UL1TR004419 awarded to ISMMS in the acknowledgment section of every publication resulting from this support. Adherence to the NIH Public Access Policy is also required.
