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                                                                       Division of Biology and Medicine




  Proposal form: Clinical Trial Unit
  Deadline for submission: February 1st, 2008

  Please note: since this application will be subject to international review, the applica-
  tion form and all accompanying documents must be completed in English.


1. Basic data

  Name of CTU

  Budget requested from
  SNF                      CHF                           (total amount for 5 years)


  Local Financial Admin.

  Starting date

  Contact Person           (person who takes responsibility towards the SNF, who is familiar with all
                           conceptual and practical aspects of the CTU, and to whom all correspondence
                           will be sent; person who will present the application in the evaluation proc-
                           ess; please enclose CV/list of publications)
  Surname, first name
  Academic degree
  Position
  Date of birth                                           Sex:
  Nationality
  Social Security Number
  Laboratory/Service
  Institute/Department
  University/Institution
  Address, No.
  ZIP, City
  Direct line
  Office line
  Fax
  E-mail
  Private address



  Phone number
  Mobile




                                                                 Swiss National Science Foundation ¦ 1
                                                                            Division of Biology and Medicine
CTU proposal form




Host Institution              (institution which will host the CTU and will provide all necessary infra-
                              structure)
Name of Institution
Institute/Department
Address, No.
ZIP, City
Office line
Fax
E-mail



Contributing Authors          (other persons beside the designated Contact Person who contributed sub-
                              stantially to the conceptual work and/or writing of the application)
Surname, First Name
Institute/Department
Type of Contribution
Surname, First Name
Institute/Department
Type of Contribution
Surname, First Name
Institute/Department
Type of Contribution
Surname, First Name
Institute/Department
Type of Contribution



Confirmation by Contact Person
I hereby confirm that all the details given in this proposal, including the appendices, are correct.
They were elaborated jointly with all co-authors and host institutions.
I hereby confirm that I am aware of the pertinent legal requirements and that the CTU will
be set up and run in conformity with these.

Place, date:                                                 Signature:




Please include the following documents with the application (where appropriate):

    □   letter of commitment from the Director (i.e., holder of budget authority) of the host institution
    □   letter of commitment from the Dean(s) of the involved university(ies)
    □   list of collaborating institutions or individuals, letter of commitment from key collaborators (insti-
        tutions or individuals)




                                                                     Swiss National Science Foundation ¦ 2
                                                                              Division of Biology and Medicine
  CTU proposal form




2. Business Plan
2.1 Overview of Organisational Structure, Organigram, Functions
and Competences
         Please provide a detailed organigram of the CTU. Positions covered should include, when possible,
          the Head of the unit, management team and clinical leadership as well as positions in legal, fi-
          nances, IT, project management, quality assessment (QA) and training staff
         Please specify how the necessary competences in clinical study design including study documents,
          trial management, epidemiology, pharmacology, biostatistics, databank design and handling, nurs-
          ing, and other disciplines to be covered will be guaranteed.
         Please provide a detailed job description for each function listed on the organigram of your CTU.
          Where appropriate, indicate names and professional background of suitable candidates or position
          holders.

  CTU Personnel
  Function
  # of Full Time Equivalents
  Job Description               □ existing position                       □ position to be established
  Function
  # of Full Time Equivalents
  Job Description               □ existing position                       □ position to be established
  Function
  # of Full Time Equivalents
  Job Description               □ existing position                       □ position to be established
  Function
  # of Full Time Equivalents
  Job Description               □ existing position                       □ position to be established
  Function
  # of Full Time Equivalents
  Job Description               □ existing position                       □ position to be established
  Function
  # of Full Time Equivalents
  Job Description               □ existing position                       □ position to be established
  Function
  # of Full Time Equivalents
  Job Description               □ existing position                       □ position to be established
  Function
  # of Full Time Equivalents
  Job Description               □ existing position                       □ position to be established
                                                                                Add other functions as needed



2.2 Operational Plan
         Please provide timetable and milestones of CTU setup and extension, including contingency plan.
         Please specify products and services delivered by the CTU and how will quality control (QC) be
          handled. Among services that should, if applicable, be included are legal (contract drafting and ne-
          gotiations with industry, insurance policies), QA, project management, drug supplies management


                                                                       Swiss National Science Foundation ¦ 3
                                                                               Division of Biology and Medicine
  CTU proposal form




         and storage, specimen storage, pharmacokinetics, pharmacovigilance, monitoring, statistics, trial
         design, trial documents design, regulatory, trial registry, trial reporting, health economics, epidemi-
         ology, medical writing (grant requests, study documents and report, abstracts, posters and publica-
         tions)
        Please describe the infrastructure of the CTU
        Please give detailed information on the day-to-day management of the CTU.
        In your operational plan please also answer the following specific questions:
         -   What are the procedures for allocation of resources to projects being conducted with the support
             of your CTU? How will equal access to CTU resources for different disciplines, other insti-
             tutes/clinics be guaranteed?
         -   How will communication within the institution and with other CTUs be assured? How do you
             envisage to coordinate local activities with other CTUs in Switzerland and abroad?
         -   Please specify organisation of QA and QC.



2.3 Financial Plan

        Please provide a comprehensive financial plan for your CTU, aimed at becoming independent of
         SNF-support after 5 years at the latest. After the third year, SNF support for CTU infrastructure will
         gradually diminish and must be replaced by other sources by the end of the fifth year (for details of
         SNF support, please refer to the Call).
        Please provide an overview chart indicating total costs for the CTU and the distribution of costs
         among different funding sources (SNF and non-SNF).
        Please include a tentative price list for services provided for different types of customers of your
         CTU.



2.3.1 Human Resources
        Salaries of CTU personnel can be charged to the SNF grant according to the local salary schemes for
         a given function and the actual contribution of this person to the CTU operations. For each position
         please indicate function and occupation rate. Please indicate total costs for salaries (incl. social
         charges) and how costs will be divided between contributors. Positions covered should include, if
         applicable, the Head of the unit, details of the management team and of the clinical leadership as
         well as legal, finances, IT, project management, QA and training staff



2.3.2 Infrastructure Costs
        Please list total infrastructural costs and indicate how costs will be divided between contributors.



2.3.3 Running Costs
        Please list total running costs of CTU and indicate how costs will be divided between contributors.




                                                                        Swiss National Science Foundation ¦ 4
                                                                                   Division of Biology and Medicine
  CTU proposal form




2.3.4 Recapitulation of financial contribution from SNF per year

                                      1st year   2nd year   3rd year    4th year   5th year          Total
   Infrastructure
   Running Costs
   Salaries (incl. social security)
   Total
                                                      Total to be carried over to first page of application.




3. Track Record
          Please list important clinical research undertaken in your institution over the last five years (with
           references). If a CTU or similar structure already exists, please specify how the investigators have
           collaborated with the CTU, and how they and their institutions envisage this collaboration in the fu-
           ture.
          Please outline the track record of key persons foreseen to run the CTU in the management of clinical
           trials, in particular multi-center trials, and their and your institutions experience in collaborating with
           partners from the industry.



4. Future Perspectives
          Please provide a long-term outlook for your CTU.




                                                                           Swiss National Science Foundation ¦ 5