Investigator Initiated Study Request Form

Principal Investigator (PI) Full Name

PI Email

PI Phone

PI Institution

Institution Phone

Institution Address

City

State/Province (Optional)

ZIP/Postal Code

Country

Title of Proposed Study

Investigational Product or Device

Background & Rationale for Study

Hypothesis

Primary Endpoint

Overview of Study Design

Study Objectives

Comparator Products to be Used (as applicable)

Site Names

Please complete details below if known. You may submit this form without completing the below for an initial concept review, but note that all fields much be completed for formal Leica Biosystems review board.

Statistical Methodology

Sample Size

Subject Type and Number

Total Study Budget

Currency

Please Confirm Currency

Complete the anticipated dates for the following milestones of the proposed study

IRB Submission Target

Enrollment Start

Enrollment End

Final Data Analysis

Please provide details on the proposed publication strategy (i.e. journal in which to publish, abstract presentation at a congress, etc.)

Please upload and confirm that the following documents are included with this proposal submission.

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PI Curriculum Vitae

Curriculum Vitae for PI at each Study Site

Itemized Budget Proposal

Evidence of appropriate approval from institution for use of human tissue (as applicable)

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Principal Investigator and Contact Information

Study Details

Statistical Methods (optional)

Budget (optional)

Milestones (optional)

Publication Strategy (optional)

Documentation (optional)