Investigator-Initiated Research (IIR) Request

Investigator-Initiated Research (IIR) Request Please submit completed request via email to: [email protected] STUDY SYNOPSIS

Study Title

Name of Test Drug/ Investigational Product

Active Pharmaceutical Ingredient

Principal Investigator Name Information Address and Academic Affiliation E-mail Phone Fax

Sub-investigator(s) Information Name Address and Academic Affiliation E-mail Phone Fax

Countries and Sites List the sites and countries in which the study is planned to take place

Objectives Primary Objective

Secondary Objectives

Tertiary / Exploratory Objectives

Study Description Study Rationale In this section, please provide a background about the disease, the study population, and the justification behind the novelty, relevance and overall importance of the proposed study and outcomes.

of 5 Study Design

Study Duration Screening Period Study Treatment Period Post-Study Treatment Follow Up Period For in-vitro or ex-vivo experiments, please provide the period of the laboratory procedures (e.g. incubation period, etc…) For epidemiology studies and studies involving medical records review, please specify the study period (e.g. Jan 2006 – Dec 2009).

Study Dates First Subject First Visit Date First Subject First Dose Date Last Subject First Visit Date Last Subject First Dose Date Last Subject Last Visit Date Statistical Analysis Report Date Final Clinical Study Report Date For in-vitro or ex-vivo experiments, please provide laboratory procedure dates

Sample Size

Study Population Includes the age group, diagnosis, background therapy, etc… For in-vitro or ex-vivo experiments, please describe the characteristics of the materials to be tested Investigator-Initiated Research (IIR) Request Please submit completed request via email to: [email protected]

Inclusion Criteria To be eligible for enrollment, a subject must meet all of the following criteria: For in-vitro or ex-vivo experiments, please describe the characteristics of an acceptable specimen to be tested 1. 2. 3. 4. 5.

Exclusion Criteria A subject with any of the following conditions must be excluded from this study: For in-vitro or ex-vivo experiments, please describe the parameters that would lead to specimen rejection and exclusion from testing 1. 2. 3. 4. 5.

Study Withdrawal Criteria A subject may be withdrawn from the study for any of the following reasons: 1. 2. 3.

Study Drug Administration Describe how the study treatment will be supplied, stored, and administered

Methodology and Study Describe the study methods, visits schedule, and procedures Procedures per visit

Study Endpoints PRIMARY ENDPOINT (Describe efficacy, safety, PK/PD, health outcomes, SECONDARY ENDPOINTS pharmcoeconomic, laboratory parameters, biomarkers,

of 5 epidemiology, etc.) 1. 2. 3. EXPLORATORY ENDPOINTS 1. 2. 3.

Statistical Methods Sample Size Determination Provide justification behind the proposed sample size, including effect size, Minimum Important Difference (MID), etc…

Statistical Methodology Describe the statistical methods that will be used to test the primary, secondary and exploratory hypotheses.

Adverse Event Reporting: Describe the mechanism of reporting of all Adverse Events Investigator-Initiated Research (IIR) Request Please submit completed request via email to: [email protected] REFERENCES: Provide an annotated list of credible references in support of the study proposal.

STUDY BUDGET: Provide or separately attach a detailed breakdown of the study budget including overhead charges if required. Provide approximate annual as well as total budget if multi-year funding is requested. Describe if other sources of funding are used for this study (NIH grant, other pharma, etc…) Specify currency (e.g. GBP, USD, EURO etc..).

PRIMARY CONTACT: Please provide the complete name, affiliation, and address of the primary contact for this proposal if other than the Principal Investigator. Include physical address, e-mail, telephone and fax numbers.