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Clinical Trials Registration Requirements

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  • Clinical Trials Registration Requirements

    ​This page summarizes clinical trials​ registration requirements for FDAAA, ICMJE and CMS.​

    FDAAA Requirements​​

    ​I. Registration

    FDAAA is a US law that requires registration of “Applicable Clinical Trials” on ClinicalTrials.gov.

    What is an Applicable Clinical Trial?

    Applicable Clinical Trials are defined as:

    • Interventional trials (drugs, biologics, devices)

    • Phase 2 – 4 (not phase 1 drug; not small feasibility device)

    • US FDA jurisdiction (e.g. IND/IDE or US site)

    • Studies initiated on or after September 27, 2007 or ongoing as of December 26, 2007

    For additional information see Elaboration of Definitions of Responsible Party and Applicable Clinical Trial.

    When Do I R​​egister?

    ​Registration must be completed:

    • Within 21 days of enrollment of 1st subject, AND

    • Updated at least every 12 months

    II. Results Reporting

    FDAAA also requires reporting of aggregate results and adverse event information.

    ​Am I Required to Submit Results for My Study? 

    Reporting of results and adverse event information is required for:

    • Interventional trials (drugs, biologics, devices)

    • Phase 2 – 4 (not phase 1 drug; not small feasibility device)

    • US FDA jurisdiction (e.g. IND/IDE or US site)

    • Studies initiated on or after September 27, 2007 or ongoing as of December 26, 2007

    • Study product approved (for any use) by FDA

    •  

    When Do I Submit Results?

    Results reporting must be completed:

    • Within 12 months of primary endpoint completion date, which is defined as the date at which the last endpoint of the primary endpoint was collected (not last subject last visit)

    • Delays are possible by request to CT.gov if you are::

      • The manufacturer of the investigational product and seeking initial approval

      • The manufacturer of the investigational product and seeking approval for a new use

      • You are requesting an extension for “good cause”

    Note: Clinical investigations of an FDA approved product that are not intended to be submitted to the FDA in support of a change in labeling, are not eligible for a delay in results reporting. This includes investigations that are conducted under IND/IDE.

     

    III. Responsible Party

    Who Is the Responsible Party?
    The Responsible Party (RP) is required to register and submit results.

    The FDA Amendments Act of 2007 (FDAAA) defines the Responsible Party as:

    • The IND/IDE holder

    • If no IND/IDE:

      • The industry, cooperative group, consortium or other external sponsor that initiated the study

      • If initiated by a Principal Investigator

        • The grantee institution (e.g. MGH/BWH)

        • If no external funding, the PI

    For additional information see Elaboration of Definitions of Responsible Party and Applicable Clinical Trial.

    International Committee for Medical Journal Editors (ICMJE) Requirements

    What is ICM​​​JE?

    The ICMJE is a group of general medical journal editors that include:

    • New England Journal of Medicine

    • Journal of the American Medical Association

    • Annals of Internal Medicine

    • The Lancet

    • The Medical Journal of Australia

    • The New Zealand Medical Journal

    • Norwegian Medical Journal

    • Canadian Medical Association Journal

    • Croatian Medical Journal

    • Dutch Journal of Medicine

    • Journal of the Danish Medical Association

    What are the ICMJE Requirements for Clinical Trials Registration?

    The ICMJE member journals will require, as a condition of consideration for publication in their journals, registration in a public trials registry.

    The ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like.  Note: Many journals that are not part of ICMJE adhere to these requirements.

    More information can be found at:
    ICMJE Obligation to Register Clinical Trials

    ICMJE FAQ

    When Do I ​Register?

    Registration must be completed:

    • Prior to enrollment of 1st subject, AND

    • Updated at least every 6 months​​

    Centers for Medicare and Medicaid Services (CMS) Requirements (Coming Soon)

    ​Contacts

    Sarah White
    Director, Human Research Quality Improvement (QI) Program
    swhite12@partners.org
    ​617-424-4137

    Emily Ouellette
    QA/QI Specialist, Human Research Quality Improvement (QI) Program
    eouellette@partners.org
    ​617-424-4136​

    ​​Resou​rces

    QI Program