Application form for associate membership Date of submission: Please note: since this application will be subject to internal review, the application form and preferably all accompanying documents must be completed in English. 1. Basic data Name of institution / organisation Contact Person Surname, first name Academic degree Position Address, No. ZIP, City Direct line Office line Fax E-mail Host Institution (if applicable) (institution which will host the CTU and may provide necessary support) Name of Institution Address, No. ZIP, City Office line Fax E-mail Advising full member (if applicable) Name of Institution Address, No. ZIP, City Office line Fax E-mail (institution which advises the applicant and will provide necessary support) Application form for associate membership – version date: 140415 Contributing Authors (if applicable) 2 (other persons beside the designated Contact Person who contributed substantially 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 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, the host institution and the advising full member of the SCTO. Place, date: Signature: Please include the following documents with the application (where appropriate): letter of recommendation from the Director of the host institution other (please specify) Name institution: Application form for associate membership – version date: 140415 3 2. Organisation 2.1 Organisational Structure, Organigram, and Overview of Functions and Competences Please provide an organigram of your Institution/Organisation. Please specify how the necessary competence in clinical study design, trial management, epidemiology, pharmacology, biostatistics, databank design and handling, nursing, and other disciplines to be covered is reached. Please provide a short job description for each function listed on the organigram of your CTU. Where appropriate, indicate names and professional background of position holders. Please specify, whether are interested to collaborate with a CTU from the CTU network and if yes, in which field(s) Institution/Organisation Personnel Function # of Full Time Equivalents Job Description Head/Coordinator of Institution/Organisation % existing position position planned to be established Function # of Full Time Equivalents Job Description Biostatistician % existing position position planned to be established Function # of Full Time Equivalents Job Description position not existing interested to collaborate with CTU Study Nurse % existing position position planned to be established Name institution: position not existing interested to collaborate with CTU Study Manager/Monitor % existing position position planned to be established Function # of Full Time Equivalents Job Description position not existing Quality Manager % existing position position planned to be established Function # of Full Time Equivalents Job Description position not existing interested to collaborate with CTU Secretary / Clinical Trial Administrator % existing position position planned to be established Function # of Full Time Equivalents Job Description position not existing position not existing Application form for associate membership – version date: 140415 Function # of Full Time Equivalents Job Description Data Manager % existing position position planned to be established Function # of Full Time Equivalents Job Description position not existing interested to collaborate with CTU Clinical Epidemiologist % existing position position planned to be established Function # of Full Time Equivalents Job Description 4 position not existing interested to collaborate with CTU Clinical Pharmacologist % existing position position planned to be established position not existing interested to collaborate with CTU Add other functions as needed Function # of Full Time Equivalents Job Description Please specify % existing position position planned to be established Function # of Full Time Equivalents Job Description position not existing interested to collaborate with CTU Please specify % existing position position planned to be established position not existing interested to collaborate with CTU Job Description Please add a short description per function or attach existing job descriptions to the application. Name institution: Application form for associate membership – version date: 140415 5 2.2 Operations Please specify products and services delivered by the Institution/Organisation. Please give a summary on the day-to-day management of the Institution/Organisation. Please also answer the following specific questions: – What are the procedures for allocation of resources to projects being conducted with the support of your Institution/Organisation? Is equal access to Institution/Organisation resources for different disciplines, other institutes/clinics available? – How do you communicate within the Institution/Organisation and with other Institutions/Organisations? How do you envisage to coordinate local activities with other Institutions/Organisations in Switzerland and abroad? – Please specify organisation of quality assessment and quality control. – Please specify your internal/external training programme. – Please specify how data-management is organised and which system is used within your Institution/Organisation. Name institution: Application form for associate membership – version date: 140415 3. Track Record Please list/summarise important clinical research undertaken in your Institution/Organisation over the last five years (single/multi-centre trials, trials with industry sponsor or sponsor-investigator, do you also act as a sponsorinvestigator, legal representative etc.) Name institution: 6 Application form for associate membership – version date: 140415 4. Future Perspectives / expectations State the motivation of your Institution/Organisation to become an associate member of the SCTO. Summarise the expectations your Institution/Organisation has in this regard. Please list/summarise important projects, strategic plans etc of your Institution/Organisation for the future. Name institution: 7