Your study involves a drug or device:

a. 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 monetary penalties and, for federally funded studies, the withholding of grant funds.

Required for Journal Publication: You intend to publish an article about your study methods and/or outcomes:a.  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. i.     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, behavioural 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.”

For a Qualifying Clinical Trial (QCT): You intend to bill insurance for routine costs of care for study participants

a.    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#.

Qualifying Criteria (All three criteria must be "Yes"):

1. Evaluates a medicare benefit
2. Has therapeutic intent
3. Enrolls diagnosed beneficiaries

            ii.     Deemed Automatically Qualifying Trial (Any one criteria must be "Yes"):

1. Is funded/supported by NIH, CDC, AHRQ, CMS, DOD or VA
2. Is supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA
3. Has an IND number: Trial conducted under an investigational new drug application (IND) reviewed by the FDA
4. rial is exempt from having an IND

NIH Clinical Trials Registration: NIH FDAAA FAQ

a.     The NIH encourages registration of all clinical trials whether required under the law or not. The NIH defines clinical trials as: 

b.     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.