Resources for Researchers

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 DMID’s 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.