Please Note: Per federal regulations, registration in clinicaltrials.gov is required for all trials that meet the FDAAA801 definition of an "Applicable Clinical Trial" and were either initiated after September 27th, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007. To determine if your trial qualifies, please visit: https://www.clinicaltrials.gov/ct2/manage-recs/fdaaa or request a CTSI-CN clinicaltrials.gov Consultation
What is this resource?
Clinicaltrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical trials on a wide range of diseases and conditions.
The purpose of Clinicaltrials.gov is to share key information with the public about current and past clinical trials. Clinicaltrials.gov captures significant summary information before and during the clinical trial as well as summary results and adverse event information of a completed clinical trial. Federal laws and regulations as well as editors of prominent medical journals require registration of a clinical trial, as described below.
Clinical trials are generally submitted (that is, registered on the website) when they begin. Information on Clinicaltrials.gov is provided by the sponsor or principal investigator (PI), who updates the information throughout the clinical trial. In some cases, results of the clinical trial are submitted after the clinical trial ends. Website commonly referred to as a "registry and results database", this website is a publicly available database of federally and privately supported clinical trials conducted in the United States.
Who can use this resource?
All Children’s National Health System Principal Investigators (PIs) are required to register their trial in ClinicalTrials.gov if it meets the definition of an "Applicable Clinical Trial" per federal regulation, FDAAA801.
NOTE: Failure to register an "Applicable Clinical Trial" will result in penalty. Penalties include civil monetary penalties and, for federally funded studies, the withholding of grant funds to the entire institution.
How much does access to this resource cost?
ClinicalTrials.gov is federally funded and offered at no cost. To see the cost of other CTSI-CN resources, please visit SPARC Request.
How do I access this resource?
To register your trial in ClinicalTrials.gov, please first request a consultation meeting with the Children's National Health System ClinicalTrials.gov liaison via SPARC Request.
Who should I contact for more information?
Presentation Recording - "What You Need to Know About ClinicalTrials.gov" given on August 24, 2018
Presentation Slides - "What You Need to Know About ClinicalTrials.gov" given on August 24, 2018