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How do I know if I need to register my research in

The "What You Need to Do When Your Research Meets the NIH Definition of a Clinical Trial" document was created as guidance for DU investigators to provide specific definitions on whether your research qualifies as a clinical trial and whether it must be registered on This guidance also provides step-by-step instructions on how to get started and how to navigate through the PRS data entry system.

How do I register my research in study records are created using a Web-based data entry system called the Protocol Registration and Results System (PRS). In order to register your research, you must have a PRS user account to create a study record.

How can I obtain a PRS User Account?

To obtain a PRS user account, please contact the DU PRS Administrators Mary Travis or Ashleigh Ruehrdanz for assistance.

How do I get the required NCT number for posting my research on

Once a study record has been created and it meets the standards established by the PRS staff reviewers, a National Clinical Trial (NCT number) Identifier will be issued directly to the Principal Investigator (or the Responsible Party who completed the registration in PRS) and then the research can be registered in the PRS, the public database.

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

    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 to obtain the NCT#.

Frequently Asked Questions