C. KENNETH AND DIANNE WRIGHT CENTER
FOR CLINICAL AND TRANSLATIONAL RESEARCH

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.
• Request assistance creating a new study record.
• Log in to ClinicalTrials.gov's registration system (Organization: VirginiaCU).

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.  Some benefits to registering a study to clinicaltrials.gov are increased recruitment, increased visibility of your study and improving the prospect of being accepted to specific journals.

What services can you get assistance with?  

The clinicaltrials.gov administrator at VCU can provide assistance with the following tasks related to clinicaltrials.gov:

• Creating a clinicaltrials.gov account
• Registering a new study to clinicaltrials.gov
• Transferring a study from/to another organization for new or departing principal investigators
• Updating content on existing record including, but not limited to, study personnel, recruitment status and related dates
• Entering results
• Uploading informed consent form(s) that require consent posting to comply with the 2018 common rule. VCU’s compliance notice #19-002 outlines which studies are required to comply.

What are the requirements of submitting a study and entering results to clinicaltrials.gov?

VCU’s Compliance Notice #17-003 for ClinicalTrials.gov Registration and Results Reporting outlines when a study needs to be registered, if and when results need to be reported and the penalties for noncompliance.

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.