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Phase I Clinical Trial Units for Therapeutics

User Requirements

  • Concept proposals require written approval by the PO and study budgets require approval by the Contracting Officer prior to initiating protocol development.
  • The Division of Microbiology and Infectious Diseases (DMID) will sponsor the investigational new drug (IND) for the study.
  • Study product will be stored in the DMID central repository.
  • The protocol must be approved by DMID prior to study initiation.
  • Protocols will be implemented within 12 months of concept approval in order to secure funding. Studies not initiated within this timeframe must undergo re-approval by the Oversight Committee before proceeding with further protocol development.

Last Updated November 13, 2012