What is ClinicalTrials.gov?

ClinicalTrials.gov is a public database developed by the US National Library of Medicine that offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions. Information available on ClinicalTrials.gov includes registration and results reporting information. More information can be found here: http://clinicaltrials.gov/ct2/info/about

This website is intended to help Rutgers Investigators understand the requirements for clinical trials registration, their responsibilities for clinical trials registration, and how to register clinical trials on ClinicalTrials.gov.

As of 07/01/2011, Investigator–initiated clinical trials conducted by Rutgers investigators that meet FDA Amendments Act (FDAAA) clinical trials registration requirements must be registered on ClinicalTrials.gov after obtaining IRB approval. For a subset of clinical trials, investigators will also be required to fulfill the FDAAA requirements for reporting results and adverse event on ClinicalTrials.gov at the end of the study. Industry-initiated or cooperative studies are usually registered by their Sponsors.

IMPORTANT NOTE: Even if your investigator-initiated clinical trial does not meet the FDAAA clinical trials registration requirements, you are strongly advised to read the International Committee of Medical Journal Editors (ICMJE) clinical trials registration requirements and consider registering your trial to comply with the ICMJE requirements for publication.