GHUCCTS

Research FAQ's

  • What resources are available through GHUCCTS?

    GHUCCTS offers various support services to help clinical research professionals navigate the stages of translational research.

    Graphic describing the five stages of translational research

    We provide:

    Please email ghuccts@georgetown.edu to get started!

  • What is SEPCOM?

    The Scientific Evaluation and Prioritization Committee (SEPCOM) is the governing committee of the Clinical Research Units (CRU). Committee members are recommended by the CRU Program Directors of respective institutions within GHUCCTS and appointed by the Principal Investigators of the CTSA grant, Joseph Verbalis, MD and Thomas Mellman, MD. We currently have 30 voting and 32 non-voting members. The priorities of the research to be performed at the CRUs are determined by SEPCOM. The committee’s primary focus is to provide peer-review of research studies and prioritization of research projects. SEPCOM advises the Participant and Clinical Interactions (PCI) leadership on overall program priorities and resource allocation based on the GHUCCTS mission and the NIH program guidelines. Periodically, SEPCOM reviews CRU operations to ensure that the CRU resources are used for the most scientifically justified and relevant projects. SEPCOM ensures that research activities reflect the diversity and quality of GHUCCTS.

    Some of the specific responsibilities of SEPCOM are:

    • Review of protocols for scientific merit, patient safety, appropriateness and need for CRU support, adequacy of data management, and biostatistical rigor.
    • Prioritization of projects for the CRU.
    • Approval of resource allocation for individual protocols. 
    • Assurance that the inclusion of women, minorities and children are appropriately considered in the design of study samples as per NIH policy.

    Learn more about SEPCOM


    How do I get my protocol approved by the SEPCOM so it can be activated on any or all of the CRUs?

    In order to submit a protocol to the Scientific Evaluation and Prioritization Committee (SEPCOM) for approval and subsequent initiation on one of our Clinical Research Units (CRU), the SEPCOM application form must be completed and submitted to the GU administration or HU administration. 

    The application must be accompanied by the i) the protocol as it was/will be submitted to the relevant IRB and ii) the study consent form. Copies of grant applications or other relevant documents should also be submitted. The SEPCOM meets on a monthly basis and a protocol must generally be received 3 weeks before the monthly meeting in order to be reviewed at the next meeting.

  • What resources are available within the Clinical Research Units?

    We have many facility, lab, and equipment services available for investigators at our clinical research units (CRU) located at Georgetown University, Howard University, and the DC Veteran's Administration. Click here to download a list of available services

  • What is a clinical trial?

    A clinical trial is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work effectively on human subjects.

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