Letter of Intent Contact Sheet

							                  Merck IInvestiigator-iiniitiiated Studiies Program
                  Merck nvest gator- n t ated Stud es Program
                      Oncollogy Templlate: Letter of IIntent
                      Onco ogy Temp ate: Letter of ntent
                                               Proposed Study Title
Study Title:
Request Date:

                                   Principal Investigator Contact Information
Name:
Title:
Address 1
Address 2
City, ST, Zip
Phone/Fax:
E-mail:

                                          Institution Contact Information
Name:
Address 1
Address 2
City, ST, Zip
Phone/Fax:
website
                                              Contracting Information
Name:
Phone/Fax:
E-mail:

                                       Letter of Intent IISP Study Information
Indication
Phase:

Number of Subjects:

Background and Rationale
  Provide background on unanswered question(s) the study is attempting to answer (do not exceed one page)




         Template: IISP Oncology LOI                  1 of 4                        Final Version: 7/07/08
Objectives
   List the objectives to correspond directly with the listed hypotheses, most studies have one primary efficacy objective
    and one primary safety objective




Hypothesis
   List the clinical Hypotheses in order of priority. Clearly distinguish between the primary and other hypotheses.




Study Design/Clinical Plan
   Provide a concise overview stating the type of experimental design




     Template: IISP Oncology LOI                         2 of 4                           Final Version: 7/07/08
List of Correlative Studies (if applicable)




Statistical Methods
   Include rationale for sample size based on the primary hypothesis. A statement of the estimated power would be helpful.




Overall Budget Requested
   Please be sure to complete budget template
Total Amount Requested:
(include overhead)
Additional sources of
funding required? (Yes/No)
If Yes, please be specific.

IISP Timelines and Study Plans

      Template: IISP Oncology LOI                      3 of 4                           Final Version: 7/07/08
Number of Sites:

Proposed Study Start Date:

Number of Subjects:

Proposed First Patient In
Date:
Proposed Last Patient Out
Date:
Expected Enrollment
Period in Months:

Publication Plan
Where are you planning to
submit for publication?
(journals, etc):
Are you planning to present
your data at a scientific
meeting?
Please list your target date
for submission of
publication.

Drug Supply Information
Drug Supplies Required
(Yes/No)?
List Drug Supplies and         Drug Name:
Amount Required:               Amount:
List Drug Supplies and         Drug Name:
Amount Required:               Amount:
Placebo Required
(Yes/No)?
Additional Sources of Drug
Supply (Yes/No). If Yes,
please specify




      Template: IISP Oncology LOI           4 of 4   Final Version: 7/07/08