Investigator Sponsored Trial (IST) LOI Submission Form
This form is to be used to submit an Investigator Sponsored Trial Letter of Intent (LOI). Each section should be
completed as fully as possible.
Send completed forms to your Medical Science Liaison and to
externalresearch@tesarobio.com. A written letter will be provided requesting a full study protocol should the LOI
be accepted. A final approved protocol and fully executed clinical study agreement are required prior to the
initiation of any study.
General Information
LOI Submission
Investigator Name
Email
Sponsor Name
Cooperative/ Network
Date
Dr. John Smith, MD
Institutional Email Address
Legal Institution and/or Organization
If involved, provide name(s) and responsibilities
LOI Overview
Study Title
Study Title
Phase
Choose one
Type
Choose one
Requested Support
Choose one
Total Number of Subjects
Enrollment Rate
(subjects/month/site)
Number of Sites
Site Country(s)
Maximum # Subjects Planned
Rate Estimate
Main plus # Sub-sites
Where the study will be conducted
LOI Details
Background & Rationale
Click here to enter text.
Study Objectives
Inclusion / Exclusion
Criteria
Schema and Intervention
Study Design and
Schedule of Procedures
Study Endpoints
Click here to enter text.
Statistical Analysis Plan
Click here to enter text.
Data Management Plan
Click here to enter text.
Publication Plan
Click here to enter text.
References
Click here to enter text.
Study Timelines
LOI Decision to Initial
Protocol Draft
Initial Protocol to IRB/EC
Approved Protocol
IRB/EC Approved Protocol
to First Patient Dose
Last Patient Dose to Draft
Publication
Support Requested
Support requested from
other entities?
v.2.3 Jul15
Click here to enter text.
Insert study schema. Templates available upon request.
Click here to enter text.
Click here to enter text.
Estimate # months
Estimate # months
Estimate # months
Estimate # months
Yes/No
Page 1 of 2
Investigator Sponsored Trial (IST) LOI Submission Form
Describe outside support
Budget Currency
Budget Estimate
Subjects Receiving
Compound
Distribution
Describe any outside support, including compound, funding, or other in-kind services
Choose one; If applicable, specify Other
Total to support all study activities; includes funding support requested from all
entities
Maximum # Subjects Receiving TESARO Compound
Choose one
TESARO Drug
Choose one
Formulation
Choose one
Average Dose
Number of Doses/Cycle
Cycle Duration (days)
Number of Cycles/Subject
Combination
Drugs/Agents
Average Dose by Arm, including units
Planned # Doses/Cycle
Cycle Length in Days
Average # Cycles/Subject
Include all drugs/agents, including chemotherapy, immunotherapy, radiotherapy, etc.
You represent and warrant that you have full authority and consents necessary for the transfer, processing and use of
all data provided in your submission, and that the information does not violate a third party’s intellectual property
rights. In submitting your proposal, you understand that TESARO may not treat the information provided as
confidential or proprietary. If you enter into an agreement with TESARO, the terms of that agreement will govern the
confidentiality of and intellectual property rights in the information you provide.
v.2.3 Jul15
Page 2 of 2