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Letter of Intent Template 2

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Letter of Intent Template 2
Letter of Intent Template 2
Created on March 2, 2011
Letter of Intent Template
Before a UMMCCoE 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
briefly address 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 this LOI does not constitute a complete CRO
submission of your protocol. (If your LOI is approved, the complete submission will come later).
Proposed Title of Study:
Principal Investigator:
Phase of Study: I I/II II III IV Pilot Not Applicable
Agent(s), Device(s) or Tool(s) to be used:
Source of agent(s): (NCI, drug company sponsor, commercially available, etc.)
Tumor Type and Stage:
Performance Status Permitted (ECOG scale): 0 <1 < 2 < 3 < 4 N/A
Abnormal Organ Function Permitted:
Letter of Intent Template 2