INTRODUCTION

    The aim of this document is to learn more about the applicant institution. The below application questionnaire shall help to better assess the capacities and abilities of an applicant institution applying for ICN membership and its allocation to the appropriate ICN membership category.

    PART A: CONTACT DETAILS AND BACKGROUND INFORMATION

    (1) Contact Information of the Clinical Trial Unit / Institution

    Name:

    Address:

    City:

    Zip Code:

    Country:

    (2) Head of Institution

    Title:

    First Name:

    Last Name:

    Tel.:

    Email Address:

    (3) Contact Person for ICN

    Function in Institution:

    Title:

    First Name:

    Last Name:

    Tel.:

    Email Address:

    (4) Type of Institution

    Other, please specify:

    (5) Legal Status

    Other, please specify:

    (6) Associated Hospital/ Institution

    Name:

    Address, if different from above:

    (7) Institutional website

    (8) Additional information

    PART B: QUESTIONNAIRE

    The questions bellow should be either answered with yes or no. If there is an (additional) open question, please fill in the information in the comment section. The ICN Steering Board will discuss and decide on the individual applications.

    Questions

    Answer

    Comment

    Questions regarding the clinical trial center and its affiliated institution

    1. Is the applicant located in a country with GCP-compliant regulations?

    2. What is the size of the associated institution/hospital/university?

    • Number of employees

    • Number of beds

    • Range of medical specialties / health area

    3. Has the applicant strong support and commitment from their management to build-up a clinical trials center?

    4. Is the applicant a central clinical trial center within its institution?

    5. Is the applicant able to fully initiate, execute and/or support the development of clinical studies on its own?

    6. What clinical research related services are offered by the applicant?

    • Study Coordination and Management

    • Quality Management

    • Data Management

    • Monitoring

    • Regulatory Affairs

    • Statistics

    • Phase I Unit

    • Research Ward (Phases II, III and IV)

    • Tech-transfer Office

    • Continuous Education and Training

    7. Total number of employees of the applicant that will provide these services (without the investigational teams)

    8. Year of the applicant's foundation

    9. Number of performed or supported clinical trials by the applicant per year

    10. Relevant publications that show the applicant's experience and/or reputation.