Why it's important

Clinical trials must be placed in a public database, ClinicalTrials.gov, as mandated by federal agencies. The trials are required to be registered when they begin and updated throughout the life of the study. Additionally, study results must be provided upon completion of the study. Monetary penalties can be applied by the agencies if the requirements are not met.

Recent Changes - January 18, 2017

The revised requirements to register applicable clinical trials now also apply to trials funded by NIH, whether they or not they are FDA-regulated. The expanded regulations also include increased penalties for noncompliance. Furthermore, several scientific journals have specified they will not publish clinical trials which have not registered.

Applicable Clinical Trials

Clinical trials funded by in whole, or in part, by National Institute of Health Definition of Clinical Trial as determined by the NIH: A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” This definition encompasses phase 1 trials of FDA-regulated drug and biological products, small feasibility studies of FDA-regulated device products, and study of any intervention not regulated by the FDA, (i.e., behavioral interventions) Trials that meet the clinical trial definition of the International Committee of Medical Journal Editors (ICMJE) that the investigator may publish. Definition as determined by ICJME: 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. Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. NOTE: Registration must occur before the first patient was enrolled. Qualifying clinical trials that will render claims for items/services to the Center for Medicare and Medicaid Services. The National Clinical Trial (NCT) number must be included on claims for items and services provided in clinical trials that are qualified for coverage as specified in the “Medicare National Coverage Determination (NCD) Manual,” Section 310.1. Definition of a Qualifying Clinical Trial under CMS Clinical Trials Policy: The subject or purpose of the trial is the evaluation of an item or service that falls within a Medicare benefit category (e.g., physicians’ service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids). The trial is not designed exclusively to test toxicity or disease pathophysiology and must have therapeutic intent. Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers, although trials of diagnostic interventions may enroll healthy patients to have a proper control group. Applicable Clinical Trials per FDAAA: Trials of Drugs/Biologics: Controlled, clinical investigations of a product subject to FDA regulations, other than Phase I. This may include interventional studies with dietary supplements. Trials of Devices: Prospective controlled trials with health outcomes, which compares an intervention with a device against a control, other than small feasibility studies. Includes Pediatric post-market surveillance studies. Applicable Clinical Trials under FDAAA also meet one of the following conditions: Checklist for Evaluating whether a Clinical Trial or Study is an Applicable Clinical Trial
  • The trial has one or more sites in the U.S.
  • The trial is conducted under an FDA Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) application
  • The trial involves a drug, biologic, or device that is manufactured in the U.S. or its territories and is exported for research
FDAAA requirements for registration exclude the following (unless funded either in whole, or in part by NIH):
  • (Non-serious/life-threatening) Phase 1 drug trials, including studies in which drugs are used as research tools to explore biological phenomena or disease processes
  • Small clinical trials to determine the feasibility of a device or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes
  • Trials that do not include drugs, biologics, or devices (e.g., behavioral interventions)
  • Non-interventional (observational) clinical research, such as cohort or case control studies

IPD Tool - Understanding Data Sharing Statements

Click below to open a PDF for our IPD Tool on Understanding Data Sharing Statements

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Who is the Responsible Party for Registering Trial and Study Results?

The responsible party is considered to the study sponsor (i.e, IND or IDE holder or the initiator of the study) or a sponsor-designated PI who is responsible for conducting the study, and has access to and control over the clinical data to analyze the data and publish the results. The PI should consult with industry sponsor to assure that posting of a trial is in accordance with terms of the study contract. A sponsor whom provides study drug only typically does not accept the registration/results reporting responsibilities.

Registration and Reporting Results

ClinicalTrials.gov Registration Guide
  • Initial Registration: No later than 21 days after enrollment of first subject
  • Interim updates: The record must be updated annually (even if nothing has changed) until the final results are reported. NOTE: Specific type of changes must be reported within 30 days.
  • Reporting Results: No later than one year after the trial’s primary completion date. This is the date when the final subject was examined or received an intervention for the purposes of collection of data for primary outcomes.

What specific information is provided to Clinical Trials.gov?

Specific information on the data elements required by FDA and NIH for registration reporting is located on the ClinicalTrials.gov Protocol Registration System information website. Data elements for protocol registration Data elements for results reporting

Responsibilities of the PI

The PI can delegate the responsibility for entering information for purposes of registration, updates and reporting of results, however, the PI remains responsible for:
  • The accuracy of the information
  • The Approve and Release actions which are required every time information is entered into the record

Informed Consent Requirements

Federal regulations require that consent forms included the following statement, without revision. This is included in the standard consent template: A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Penalties for failure to register a clinical trial

Failure to register, or provide incomplete/false information (including updates subsequent to initial registration) may include monetary penalties of up to $10,000 per incident and/or per day, non-compliance notification from the FDA, and for federal sponsored studies, the withholding or recovery of grant funding. NIH grantees are required to certify compliance with registration/reporting requirements in grant applications and progress reports.



The University of North Carolina at Greensboro (UNCG) recognizes that a critical component of its mission is supporting fundamental research as well as developing relationships and participating in the worldwide academic and business community to further the pursuit of knowledge. The University is committed to openness in its research activities and freedom of access and dissemination of information for the advancement of the common body of knowledge and scientific discoveries. As a participant in a diverse academic, research, and business community, UNCG is committed to complying with U.S. export controls laws and regulations that apply to its activities.

The Departments of Commerce, State, and Treasury administer the primary controls on exports of goods, commodities, and information.

  • The Department of Commerce regulates the export of items and information that have civil applications,
  • The Department of State regulates the export of items that have military applications or that relate to space, and
  • The Department of the Treasury enforces country-specific embargoes and financial sanctions on individuals, organizations and countries.

These agencies govern the shipment or transfer of export-controlled technical data, information, materials and equipment to destinations outside the United States, as well as the provision of access to certain export-controlled technical data, information, materials or equipment to non-U.S. persons within the United States (a “deemed” export). In addition, the Office of Foreign Assets Control (OFAC) regulations under the Department of Treasury impose sanctions and embargoes on transactions or exchanges with designated countries, entities and individuals. In certain circumstances, these agencies may require the University to secure a license before any items or information is exported to another country or shared with a foreign national. Getting a license takes time, potentially several months to a year, depending upon the circumstances. Contact the university ECO as soon as possible for help in determining the need for one.

Penalties for export control violations are substantial, including significant fines, debarment from participation in federal contracting, loss of export privileges, and in some cases imprisonment. In addition to these severe penalties, the potential reputational damage to an institution from violation of these laws could be difficult to repair, possibly resulting in lost opportunities for attracting world-class researchers and/or decreased access to research funding through private industry and government sources.

Civil Penalties Adjustment (06.07.16)

The Department of State is implementing “catch-up” adjustments to the maximum amounts of the civil monetary penalties (CMPs) it assesses.

For each violation of 22 U.S.C. 2778, an amount not to exceed $1,094,010 (previously $500,000);
For each violation of 22 U.S.C. 2779a, an amount not to exceed $795,445 (previously $500,000); and,
For each violation of 22 U.S.C. 2780, an amount not to exceed $946,805 (previously $500,000).