Investigator-Initiated Research (IIR) Request

Please submit completed request via email to:

STUDY SYNOPSIS

Study Title
Name of Test Drug/
Investigational Product
Active Pharmaceutical Ingredient
Principal Investigator Information / Name
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.
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
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
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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
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Study Withdrawal Criteria / A subject may be withdrawn from the study for any of the following reasons:
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Study Drug Administration / Describe how the study treatment will be supplied, stored, and administered
Methodology and Study Procedures / Describe the study methods, visits schedule, and procedures per visit
Study Endpoints
(Describe efficacy, safety, PK/PD, health outcomes, pharmcoeconomic, laboratory parameters, biomarkers, epidemiology, etc.) / PRIMARY ENDPOINT
SECONDARY ENDPOINTS
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3.
EXPLORATORY ENDPOINTS
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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

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.

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