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Clinicaltrials.gov

What is clinicaltrials.gov?

Clinicaltrials.gov is a US government web-based resource maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). The database allows patients/research participants, family members, health care professionals, researchers, and the public with access to details of federally and privately funded clinical studies.

Definition of a clinical trial for the purpose of registration:

If a research project meets any one of the following definitions, the trial must be registered at clinicaltrials.gov prior to enrollment of the first participant.

The Food and Drug Administration

The FDA requires registration for studies that meet the definition of an "applicable clinical trial" (ACT) defined as follows:

For any trials of drugs and biologics: Controlled clinical investigations, other than phase 1 investigations, of a product subject to FDA regulation.
For trials of biomedical devices: 1) Controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, 2) pediatric post-market surveillance studies required by the FDA

As discussed in more detail in the Final Rule, and as reflected in 42 CFR 11.10, ACTs generally include interventional studies (with one or more arms) of FDA-regulated drug, biological, or device products that meet one of the following conditions:

The trial has one or more sites in the United States
The trial is conducted under an FDA investigational new drug application or investigational device exemption
The trial involves a drug, biological, or device product that is manufactured in the United States or its territories and is exported for research

NIH

National Institute of Health

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Definition Of A Clinical Trial

ICMJE

International Committee of Medical Journal Editors

"The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes.”

Journals Following ICMJE Recommendations

CMS

Centers for Medicare and Medicaid Services

Registration in ClinicalTrials.gov is required for all “Qualifying Trials”, which are clinical trials that are qualified for coverage as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1. Clinical trials that are qualified for coverage must include The National Clinical Trial (NCT) number on claims for provided items and services.

**Some funders have specific registration requirements, timelines, or regulations related to clinicaltrials.gov. Be sure to read your award terms and conditions carefully to ensure you are in compliance with trial registration requirements.

Helpful Links

Resources

Who is responsible for clinicaltrials.gov registration?

Applicable Clinical Trials must be registered at Clinicaltrials.gov no later than 21 days after enrollment of the 1^st participant per NIH and FDA requirements. ICMJE requires registration prior to enrollment of the first participant.

The Responsible Party for a clinical trial must register the trial and submit results.

The study record needs to be maintained and updated throughout the course of the study. The Responsible Party should confirm the accuracy of the study record prior to releasing the record for review each time it is updated.

**Although most industry-sponsored clinical trials are registered by the study sponsor, it is the responsibility of the CNE site principal investigator to ensure trials conducted at CNE sites are registered with accurate information at clinicaltrials.gov. The CNE Site PI should request the NCT number from the industry sponsor for their records and for inclusion on study-related Medicare claims as required by CMS regulations.

The Responsible Party is defined as:

The sponsor of the clinical trial (e.g. Industry Sponsor, Federal Sponsor, or Investigator-Initiated)
The Principal Investigator of an Investigator-Initiated trial or if designated by a sponsor, grantee, contractor, or awardee. The principal investigator can be designated as the responsible party so long as they are responsible for conducting the trial, have access to and control over the data from the clinical trial, have the right to publish the results of the trial, and have the ability to meet all of the requirements under the regulation for submitting and updating of clinical trial information

How do I register a trial?

Clinical trials are registered through a web-based protocol registration system (PRS). Instructions to register a trial can be found here.

Step-by-step instructions for entering registration information into the PRS can be found here.

To request a PRS account contact your IRB administrator.

What is the deadline to post results?

Federal regulations and NIH policy require results information, including adverse events, be posted to clinical trials no later than 1 year after the primary completion date indicated in the registration record. Information on how to submit results can be found here.

Results submission 1-on-1 assistance: email register@clinicaltrials.gov to schedule a teleconference

How often should I update my trial information?

Information such as Start Date, Recruitment Status, and Completion Date are required to be updated within 30 calendar days of a change in status. More information can be found here.

During the registration process, the Responsible Party must respond to QA review comments within 15 days. Corrections are required within 25 days during the results reporting phase.

As a general rule study records should be updated frequently (every 6-12 months) to ensure information is accurate and up to date. Steps to edit your study record are available here.

What happens if I don't register my trial?

Failure to register or update a trial may result in:

Monetary penalties of up to $12,103 for failing to submit or submitting false or misleading information. After 30 day notification period the fine may go up to $12,103/day until resolved.
For federally funded grants withholding or recovery of federal research funds. Compliance with trial registration requirements may be used in future funding decisions.
Disqualification from publication in ICJME member (or other) journals
Non-compliant records will be noted publicly at clinicaltrials.gov.

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