Investigational site PIs or outside collaborators should submit concept proposals to the project officer (PO). The PO is a Division of Microbiology and Infectious Diseases (DMID) staff member responsible for oversight of the Phase I Clinical Trial Units for Therapeutics contracts. The PO serves as the primary contact with the contract sites and oversees their technical performance.
All concept proposal packages submitted for review should describe the study objectives, rationale for the proposed clinical trial, recruitment and site plan, protocol timeline, including specific milestones for protocol development and initiation, requested personnel and the study budget, as well as any information the branch determines is relevant to the evaluation of the project.
The PO will forward the concept to the applicable DMID branch chief. Those concepts assigned high priority by the branch are returned to the Phase I Clinical Trial Units PO for submission to the VTEU and Phase I Clinical Trials Oversight Committee. The Oversight Committee is composed of senior DMID staff representing all branches and offices.
Last Updated November 13, 2012