THE ROBERT H. LURIE COMPREHENSIVE CANCER CENTER OF NORTHWESTERN UNIVERSITY CLINICAL RESEARCH OFFICE
Letter of Intent Template Before an institutional protocol is written, a Letter of Intent should be completed, signed by the Disease Section Leader and submitted for approval to the Clinical Protocol Scientific Review and Monitoring Committee. This letter should briefly address all of the following points. Use additional pages if necessary. If a category does not apply, write “N/A”. Send to Clinical Research Office, 676 N. St. Clair Street, Suite 1200, Chicago, IL 60611. Proposed Title of Study:
Principal Investigator: Phase of Study: I I/II II III IV Lab 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): Abnormal Organ Function Permitted:
0
<1
<2
<3
<4
N/A
Prior Therapy Permitted (Surgery, Chemotherapy, Hormones, Biologics, Radiation):
Rationale/Hypothesis:
List References:
Treatment Plan:
Laboratory Correlates:
Primary/Secondary Endpoints:
Statistical Considerations:
Proposed Sample Size (provide rationale):
Projected Dates of Accrual (MM/YY to MM/YY): Estimated Annual Accrual: List any other institutions that will participate:
Funding Source (if applicable): List Competing Studies Currently Open:
With respect to any competing studies, what will be the priority of this study?
Date _________________ Date _________________
Principal Investigator’s signature_____________________________________ Disease Section Leader’s signature ___________________________________