Investigator Initiated Studies (Iis) Request Form

INVESTIGATOR INITIATED STUDIES (IIS) REQUEST FORM

C you must complete all fields and send this form along with the following information below to:

Bonnie Astete

Professional Education and IIS Grants Coordinator

Eisai Inc.

Medical Affairs Department

100 Tice Boulevard

Woodcliff Lake, New Jersey 07677

ü Hard copy cover letter on institutional letterhead with principal investigator signature and title of grant request

· The request letter must include the following information:

· A statement requesting funds and/or drug supplies and a short description of the IIS request

· A statement declaring to whom the funds should be paid to (provide contact and address details)

· Tax ID number of the institution

· Wet ink signature by the appropriate representative

· The subject line of the letter should read as follows: “Subject: IIS Request; <Product Name>;<Title of Program>

· Include full contact, phone, fax, address and email information

ü IIS Request Form

ü Site Information Form

ü Budget on separate sheet (s)

ü Hard copy of principal investigator CV

OGC TRACKING NUMBER: ______(to be completed by IIS Coordinator)

IIS PROTOCOL SYNOPSIS

Protocol Title: / [Insert the full title as it appears in the protocol.]
This same title should appear on page 1 of this form.
Principal Investigator Name: / [Insert name]
Principal Investigator Contact Information: / [Insert address, phone and fax number, and e-mail address]
Institution Name(s): / [Insert Institution where study will be conducted]
Do you plan on using other Institutions or centers to conduct study?
If yes, please list names and address: / YES NO
[Insert name(s) of other Institution(s) or center(s)]
Rationale: / [List the major reasons why the study should be conducted. Provide a brief summary of information gathered from past studies, and conclude with the reason this study is taking place. Include justification for any placebo control.]
Study Design: / [Insert one sentence including treatment duration, blinding, control agent, randomization, and treatment sequence (e.g., parallel groups, etc).]
Objectives: / Primary: [Insert the primary objective(s)]
Secondary: [Insert the secondary objective(s)]
Subjects and Centers: / [Insert a one-line summary of the study population, total number of subjects, subjects per each arm, etc.]
Inclusion/Exclusion Criteria: / [Insert all the inclusion criteria.]
Exclusion Criteria: / [Insert all the exclusion criteria.]
Other Therapy: / [If required, split the therapies into prior and concomitant therapy. Mention any therapy that will be specifically allowed or disallowed by the protocol.]
Length of washout period will be [Insert length of washout period]. (Delete this statement if study has no washout period.)
Efficacy Measures: / [List all assessments with a descriptive statement and frequency for each: include clinical, laboratory, radiographic, and subject self-assessment.] (If a Quality of Life, patient-related outcome, or other self-assessment is used, note if translation will be required.)
Statistical Analysis: / [Specify power, sample size calculations, statistical plan, and whether there will be interim analyses]
[Insert criteria for evaluability including intent to treat, per protocol, and safety population]
Data Collection: / [Describe methods of collecting study data for example CRF, IVRS]
Study Drug Regimens: / [Insert dose, frequency, route, and duration for both investigational drug and any comparative drug.]
Study Drug Requested Per Patient: / [Provide exact amount of drug and/or placebo per patient]

Are Clinical/Drug Supplies Requested? (check only 1 box): ‘YES’ ‘NO’

Clinical Supply Routing Information

If Clinical/Drug Supplies are requested, please provide name and address to whom supplies should be shipped (if different from investigator name and address as specified above):
NAME who supplies should be sent to:
ADDRESS where supplies should be shipped to:
Total study drug amount in tablets:

(Please note the following compounds are available with matching tablets):

<product name> / Xct X mg per bottle
Total Active tablets
Total Placebo tablets
Amount of Pure Substance
Estimated Length of Enrollment: / [Insert duration of time in weeks, months or years. First patient in to last patient out]
Estimated Study Duration: / [Insert approximate number of months from fully executed contract to completion of all study-related activities]
Potential written outcomes of this study (check all that apply): / Final Study Report Submit for Presentation at scientific conference
Submit for Publication Submit Abstract/Poster at scientific conference
FUNDING requested:
Must be on separate sheet / Insert total Budget requested as well as budget breakout please note that the Grant Committees do NOT fund capital equipment or personnel/salary costs:
1) Total Budget requested: $ [insert amount]
2) Budget specifics outlined as follows:
a) Insert per patient cost;
b) Insert each specific item and related estimated cost

Contract Routing Information

NAME who contract should be sent to (if different from Principal Investigator):

Financial Routing Information

PAYEE NAME (name funds should be made out to):
TAX ID #:
ADDRESS check should be mailed to:
Other sources of funding: / The following other current sources of funding for this study are:
[Insert other current sources of funding including NIH grants and other company-sponsored grants]
The following other pending sources of funding are:
[Insert other pending sources of funding]
Special Equipment/Measures: / Special equipment required for this study includes [insert any special equipment]. Additionally, [insert any laboratory tests] for [indicate safety and/or efficacy] will be required during the study.
Research Team Members/Co-Investigators and all others Responsibilities: / [Insert listed members with contact information]
REFERENCES: / [Insert references applicable to this proposal – or – provide a separate attachment as a word document]
List of Investigator Publications and CV:
Additional Comments:

PLEASE BE SURE TO INCLUDE THE FOLLOWING:

ü Hard copy cover letter on institutional letterhead with principal investigator signature and title of grant request

ü IIS Request Form

ü Budget on separate sheet(s)

ü Hard copy of principal investigator CV

OGC TRACKING NUMBER: ______(to be completed by IIS Coordinator)