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Created on March 2, 2011
THE UNIVERSITY OF MASSACHUSETTS MEMORIAL CANCER CENTER OF EXCELLENCE
LINICAL RESEARCH OFFICE (CRO)
Letter of Intent Template
Before aUMMCCoE or University of Massachusetts investigator writes an institutional protocol for any
interventional study that does not receive scientific review from an NCI-approved review agency, he or she
must submit a Letter of Intent (LOI) to the Protocol Review Committee (PRC) for approval. Before the LOI
is presented to the PRC for approval, the Scientific Review Coordinator (SRC) will obtain approval from the
Disease Section Leader via e-mail. An LOI is not required for a chart review or lab-based study.
Pharmaceutical sponsored studies are also exempt from LOI submission and review. This letter should
brieflyaddress all of the following points. Use additional pages if necessary. If a category does not apply,
write “N/A”. Submit a completed LOI electronically to the current SRC, Annette Larsen, RN, BSN,
Annette.L[email protected]g. Please note that thisLOIdoes not constitute a complete CRO
submission of your protocol. (If your LOI is approved, the complete submission will come later).
Proposed Title of Study:
Phase of Study: I I/IIIIIIIIVPilotNot Applicable
Agent(s), Device(s) or Tool(s) to be used:
Source of agent(s): (NCI, drug company sponsor, commercially available, etc.)
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