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Functions

Effective May 1, 2018 the Office of Clinical Trials fee charged to sponsors is $1000 per study. This fee does not apply to federally-funded studies or investigator-initiated studies (SBU investigators).

OCT FUNCTIONS

  1. To track all industry-funded clinical trials in order to assess the feasibility of the study and resources needed.
  2. To review sponsor proposed budget/payment terms.
    Budgeting services include:
    • Assistance with budget development,
    • Billing compliance requirements: SOC vs research procedures,
    • Cost analysis of study procedures to ensure Institutional costs are covered, 
    • Budget negotiations,
    • Assistance with Clinical Trial Management System (CTMS) for more efficient study management
  3. To maintain a database of active trials to assist with subject recruitment.
  4. To match sponsors with investigators.
    The OCT helps Industry sponsors and Contract Research Organizations (CROs) identify investigators with the research experience and expertise to conduct their clinical trials at SBM.
  5. To mentor new investigators and coordinators.
    The OCT serves as the point of contact for questions related to clinical trials, assisting researchers, staff, and departments with expert resources for information on the conduct of clinical research. In addition, the OCT serves as a liaison to the Office of Research Compliance Sponsored Programs, Grants Management, and UH Finance Dept.