ClinicalTrials.gov Registration

Why Do I Need to Register My Study?

• Required by Your Funding Source

  NIH Clinical Trials Registration: NIH ClinicalTrial FAQ and NIH FDAAA FAQ

  The NIH encourages registration of all clinical trials whether required under the law or not. The NIH defines clinical trials as:
  "... a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective."

• Required for Journal Publication

  You intend to publish an article about your study methods and/or outcomes:
  
  The International Committee of Medical Journal Editors (ICMJE) requires, and recommends, that all medical journal editors require, as a condition of consideration for publication, registration of [all] clinical trials in a public trials registry at or before the time of first patient enrollment.
  
  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 cause-and-effect 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. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events."

• Required by Law

  Your study involved a drug or device:
  
  FDAAA (U.S. Public Law 110-85, Food and Drug Amendments Act of 2007) requires registration of all Applicable Clinical Trials in ClinicalTrials.gov

  Applicable Clinical trials generally include interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the U.S., involves a drug, biologic, or device that is manufactured in the US (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE).
  
  FDAAA establishes penalties for failure to comply with registration or results submission requirements. Penalties include civil penalties and, for federally funded studies, the withholding of grant funds.

• Required for Billing

  For a Qualifying Clinical Trial (QCT), you intend to bill insurance for routine costs of care for study participants:
  
  The Center for Medicare and Medicaid Services (CMS) requires a clinical trial identifier (NCT#) be reported on all billing claims for items/services related to a qualifying clinical trial. If your study will bill routine costs to Medicare or any other insurer, the study must be registered on ClinicalTrials.gov to obtain the NCT#.

Frequently Asked Questions

• My study is not yet IRB-approved. Can I still enter it on ClinicalTrials.gov?

  Yes, you can! ClinicalTrials.gov will allow registration of the study prior to getting IRB approval if the Overall Recruitment Status of the study is “Not yet recruiting.” IRB approval must be obtained before the study’s Overall Recruitment Status is changes to “Recruiting”. When IRB approval is obtained, update the protocol registration and release the study to ClinicalTrials.gov for review and processing.

• Can I register a study after it has started, has closed to recruitment, or has completed?

  Yes, you can register a study on ClinicalTrials.gov at any time. However, FDAAA Section 801 requires applicable clinical trials to be registered within 21 days of enrollment of the first participant. ICMJE journal (and other journals) require registration of all clinical trials before enrollment of the first participant.

• Am I required to submit the results of non-applicable clinical trials to ClinicalTrials.gov?

  Results submission for non-applicable clinical trials is not required (for example, a behavioral study).

• What about results entry if my trial is terminated and no participants were enrolled?

  If no participants were ever enrolled in the trial, no results must be reported. Remember to change the Overall Recruitment Status to “Withdrawn.”

• It's time to report the results of our trial on ClinicalTrials.gov, but the principal investigator is still analyzing the data and writing the manuscript and does not want to publicly disclose the results until accepted for publication. What should we do?

  The data must be reported on ClinicalTrials.gov as soon as possible. The ICMJE editors will not consider results data posted in the tabular format required by ClinicalTrials.gov to be prior publication.

  Communication with the journal regarding the legal obligatory requirements may also be useful. It’s unlikely that the journal would refuse a manuscript when the institution/investigator is mandated by law to disclose publicly. However, if the trial was not registered according to the ICMJE journal requirements (prior to enrollment of first participant), the journal may take issue with that and reject the manuscript on that basis.

• Are data reviews or exempt research excluded from registration and results reporting?

  Because data reviews are retrospective and largely observational in nature and, in general, exempt research studies are not controlled clinical trials, nor involving an FDA-regulated intervention, they would not need to be registered or reported on ClinicalTrials.gov.

  However, the ICJME may have a different opinion if exempt research involves any of the following:

  • Drugs;
  • Surgical procedures;
  • Devices;
  • Behavioral treatment;
  • Dietary interventions;
  • Process-of-care change;
  • Biomedical or health-related measures including pharmacokinetic measures and adverse events.
• The primary outcome of our trial has been completed, but secondary outcome data is still being collected. When do I need to report results?

  Though there is no official guidance, ClinicalTrials.gov generally advises completing data entry ASAP but not later than 12 months after data collection has ended for that measure. If data collection ongoing, it is a good idea to provide the anticipated posting data for that measure so it is clear to the public when the information will be made available.

• What "phase" do I choose for my behavioral trial or device trial?

  For studies that do not involve a drug or biologic, such as behavioral interventional studies or device trials, select ‘Not Applicable.'