Wright Center

CLINICALTRIALS.GOV

The ClinicalTrials.gov administrator at the Wright Center is available to help researchers manage their ClinicalTrials.gov study records.

Quick links:

• Is my study a clinical trial? – a decision tool
• Request a VCU ClinicalTrials.gov account
• Log in to ClinicalTrials.gov's registration system

What is ClinicalTrials.gov?

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.

What studies need to be registered at ClinicalTrials.gov?

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.

NIH provides case studies to help identify clinical trials. You can also complete the REDCap decision tool to help you determine if your study needs to be registered.

Why should I register my study?

There are scientific benefits to all studies being properly registered:

• Help with recruitment
• Identify ongoing or unpublished studies asking the same question to avoid duplication and assess feasibility
• Journals following the ICMJE requirement won’t publish papers without registration

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.

Where can I get help?

If you have questions or need help with your registration please contact the ClinicalTrials.gov administrator at cctrctgov@vcu.edu or 804-828-9226.