CLINICALTRIALS.GOV

Frequently Asked Questions

What is ClinicalTrials.gov?

ClinicalTrials.gov is a publically available database maintained by the National Institutes of Health (NIH) and the National Library of Medicine (NLM). The website provides information about clinical studies to study participants, their families, health care professionals, the research community, and the general public. Registration and reporting requirements are governed by Food and Drug Administration Amendments Act (FDAAA) Final Rule, NIH policy, the International Committee of Medical Journal Editors (ICJME) policy, and VCU policy.

What are the federal requirements for registration and results reporting?

The FDAAA Final Rule expands the legal requirements for submitting registration and results information for certain clinical trials involving U.S. Food and Drug Administration (FDA)-regulated drug, biological and device products to ClinicalTrials.gov. The National Institutes of Health issued a complementary policy for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded clinical trials, including those not subject to the final rule.

What are the VCU requirements for registration and results reporting?

VCU faculty members are responsible for registering investigator-initiated and NIH-funded clinical trials and maintaining their study record on ClinicalTrials.gov. Per VCU policy, all studies that meet the ICJME definition of a clinical trial must be registered by the responsible party. Trials are registered and results are reported using the ClinicalTrials.gov Protocol Registration and Results System (PRS).

How do I know if my study qualifies as a clinical trial?

VCU follows the ICJME definition of a clinical trial, which is "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." The responsible party is defined as an investigator who meets any of the following criteria:

  • Sponsor-investigator (initiates and takes responsibility for clinical investigation)

  • Recipient of funds for any clinical trial funded in whole or in part by NIH

  • Holder of an Investigational New Drug (IND) or Investigational Device Exemption (IDE)

How do I get started with registering my study?

To request a PRS account, submit a ClinicalTrials.gov account request form.

To contact the ClinicalTrials.gov Program Administrator, email CCTRCTGOV@vcu.edu

ADDITIONAL RESOURCES

SOURCE DOCUMENTS

Cite & Submit: UL1TR002649

Publications supported by the Wright Center must cite the CTSA Grant number (UL1TR002649) and comply with the NIH Public Access Policy. We rely on these citations as a critical performance measure when reporting annual productivity to the NIH.