Participant and Clinical Interactions

  1. What's It All About?
  2. Who is Responsible?
  3. Tell Me More.
  4. How Do I Apply?

SEPCOM Information

SEPCOM Meeting Dates and Submission Deadlines

  • Complete a Scientific Evaluation and Prioritization Committee (SEPCOM) application. | Download Application
  • Studies that are GHUCCTS-funded and/or will be utilizing more than one GHUCCTS' institution, please submit your IRB application to GHUCCTS IRB. Please use this SEPCOM - GHUCCTS IRB review summary as a guide to this streamlined review process. Note that the SEPCOM review must occur prior to the GHUCCTS IRB review.
  • Submit the SEPCOM application as an attachment to ghucctscruadmin@georgetown.edu, or to gcrc@howard.edu for Howard University protocols.
  • Once the complete study application is submitted, it will go to the SEPCOM for review. The source of study funding, as well as the study's prior level of review, determines the type of review the Committee will carry out. Please see this reference grid for details.
  • You may contact ghucctscruadmin@georgetown.edu or your institution's respective Program Coordinator, if you have any questions about the process.
  • CRU Nurse Managers can assist you if you have questions about clinical support services available from the CRU.
  • If there are any concerns about the study, you will receive a contingency letter asking you to address the concerns prior to final approval.
  • Once the study has received both IRB and SEPCOM approval, you are ready to start accessing CRU resources.
  • You must schedule an initiation meeting with the CRU(s) you intend to utilize. The initiation meeting is held to train the CRU staff on protocol procedures. You will be provided a copy of the CRU initiation meeting notes and staff sign-in sheet for your records. Your study will be assigned a CRU primary clinical liaison if initiated on the GU-CRU. This CRU staff member will be your primary contact for your study. S/he will complete flow sheet development, which will be used to document the procedures conducted on the CRU, and the protocol orders.