The ClinicalTrials.gov administrator at the Wright Center is available to help researchers manage their ClinicalTrials.gov study records.
ClinicalTrials.gov is the largest registry of clinical trials and observational studies in the world. It was built and is run by the U.S. National Library of Medicine (NLM), part of the National Institutes of Health.
The International Committee of Medical Journal Editors (ICMJE) requires registration at or before the time of first participant enrollment.
VCU’s Compliance Notice #17-003 for ClinicalTrials.gov Registration and Results Reporting states: “Virginia Commonwealth University (VCU) requires registration within ICMJE’s timeline of all studies meeting the NIH definition of clinical trial.”
NIH defines a clinical trial as a “research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” This includes mechanistic, exploratory, pilot and early phase studies.
There are scientific benefits to all studies being properly registered:
For many studies, registration is legally required. The FDA is authorized to impose fines of $12,000 or more, when they first find out a study isn’t registered, and more than $12,000 for each day until it is corrected. Remaining or future grants funds can also be withheld.
If you have questions or need help with your registration please contact the ClinicalTrials.gov administrator at firstname.lastname@example.org or 804-828-9226.