Study Registration and FDA Submission

Those responsible for conducting a clinical trial must ensure they are in compliance with the trial registration requirements of the Food and Drug Administration (FDA), the International Committee of Medical Journal Editors (ICMJE), and, as needed, other organizations with policies on clinical trial registration for transparency and publication. Section 801 of the Food and Drug Amendments Act, known as FDAAA 801, requires registration of studies meeting the definition of Applicable Clinical Trial on a government website: ClinicalTrials.gov. 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.

Effective January 1, 2015, Center for Medicare and Medicaid Services (CMS) requires a clinical trial identifier (NCT#) be provided on all billing claims for services related to a qualifying clinical trial(s).

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#.

Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)

An Investigational New Drug Application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug that is not the subject of an approved new drug application. IND regulations are contained in Title 21, Code of Federal Regulations, Part 312. Copies of the regulations, further guidance regarding IND procedures, and additional forms are available from the FDA Center for Drug Evaluation and Research, Drug Information Branch (HFD-210), 5600 Fishers Lane, Rockville, Maryland 20857, telephone (301) 827-4573 or toll free at 1-888-INFOFDA. In addition, forms, regulations, guidance and a wide variety of additional information are available online on the FDA website.

IDE Approval Process

Investigations covered under the IDE regulation are subject to differing levels of regulatory control depending upon the level of risk. The IDE regulation distinguishes between significant and nonsignificant risk device studies and the procedures for obtaining approval to begin the study differ accordingly. Also, some types of studies are exempt from the IDE regulations.

Who Must Apply for an IDE

The sponsor of the clinical trial is responsible for submitting the IDE application to the FDA (§812.40) and obtaining Institutional Review Board (IRB) approval before the study can begin. Foreign companies wanting to conduct a clinical study in the U.S. MUST have a U.S. sponsor (§812.18). Under certain circumstances, the clinical investigator may wish to submit an IDE and would, therefore, also act as the sponsor of the study.

When to Apply

Investigators with UT affiliation will obtain IDE Approval from the UT Health Science IRB. For significant risk device studies, in addition to IRB approvals, the sponsor must also have an approved IDE from FDA prior to beginning the study at any site. The review of applications by the FDA and the IRBs are independent and, therefore, may be submitted simultaneously.