Arbeitsgemeinschaft der Schweizerischen Ethikkommissionen für die Forschung am Menschen Communauté de travail des Commissions Suisse d’éthique pour la recherche sur l'être humain AGEK CT CER (All text fields are limited in size. Input beyond the limit cannot be recorded in this form) Applicant: (Lead) Ethics Committee: Name: Other ECs involved: First name, last name, title Organization: Organization Street: Street, Number ZIP/City: ZIP City BE EKNZ GE SG TG TI VD VS ZH Research Project Application Form (Base Form, Basisformular, Formulaire de base) SNCTP number: Project number: Title: Should be the same as the title of the protocol. Need to be in English for clinical trials (Art. 3 HFG/LRH) Public Short title: 100 characters max. Acronym: 20 characters max. Protocol Summary: Use simple, non technical language, 2000 characters max. www.swissethics.ch version 1.12, 15.04.2014 1 von 7 Arbeitsgemeinschaft der Schweizerischen Ethikkommissionen für die Forschung am Menschen Communauté de travail des Commissions Suisse d’éthique pour la recherche sur l'être humain AGEK CT CER Date submitted: 01/01/2014 Role: Risk category Clinical trial Choose Not a clinical trial, but involving persons Choose Project involving biological samples or existing data only Choose 1. Existing biomaterial or genetic data Yes No If yes, Choose 2. Existing health related non-genetic data Yes No If yes, Choose 3. Deceased persons Yes No 4. Embryo and fetuses Yes No Purpose: Choose Target Sample Size: 000 in Switzerland 000 total Key inclusion criteria: Free text, 280 characters max. Key exclusion criteria: Free text, 280 characters max. Minimal/Maximal age of study subjects: Gender of study population: Choose Start: 01/01/14 Vulnerable Population: adolescents children embryos emergencies pregnant women unable to consent End: 01/01/14 none Countries of recruitment (in addition to Switzerland): AT DE ES FR IT UK USA other Health condition(s) or problem(s) studied: For instance, type of disease. Free text, 350 characters max. Intervention(s): Free text, 700 characters max. www.swissethics.ch version 1.12, 15.04.2014 2 von 7 AGEK Arbeitsgemeinschaft der Schweizerischen Ethikkommissionen für die Forschung am Menschen Communauté de travail des Commissions Suisse d’éthique pour la recherche sur l'être humain Primary outcome(s)/endpoint(s): Secondary outcome(s)/endpoint(s): Free text, 140 characters max. Free text, 250 characters max. Information on Financing Type Source Amount in kF CT CER % Please choose Please choose Please choose Please choose The study is necessary to complete a: Choose Fill out for clinical trials ONLY Phase: Choose Clinical trial including: Choose Name of Primary Registry: Blinding: Choose Randomisation: Choose 70 characters max. Public title in English: Free text, 200 characters max. Public title in Swiss national language (de, fr, it): Free text, 200 characters max. Lay summary in Swiss national language (de, fr, it): Free text, 2000 characters max. www.swissethics.ch version 1.12, 15.04.2014 3 von 7 AGEK Arbeitsgemeinschaft der Schweizerischen Ethikkommissionen für die Forschung am Menschen Communauté de travail des Commissions Suisse d’éthique pour la recherche sur l'être humain CT CER Fill out for studies involving existing samples, or existing health related data Purpose of use of samples, and/or health related data (Art. 39a HFV/ORH) : Free text, 350 Characters max. Description of the samples, and/or health related data (Art. 39b HFV/ORH): Free text, 350 Character Description of the group of persons who are authorized to send samples, and/or data (Art. 39c HFV/ORH): Free text, 350 Character Description of the group of persons who are authorized to receive samples, and/or data (Art. 39d HFV/ ORH): Free text, 350 Characters max. www.swissethics.ch version 1.12, 15.04.2014 4 von 7 Arbeitsgemeinschaft der Schweizerischen Ethikkommissionen für die Forschung am Menschen Communauté de travail des Commissions Suisse d’éthique pour la recherche sur l'être humain AGEK CT CER Address Page 1a) Address for general queries 4) CRO, Click here if none: First, last name Address 1 Address 2 Zip Code City Email Telephone First, last name Address 1 Address 2 Zip Code City Email Telephone 1b) for scientific queries 5) Address for billing the EC’s fees First, last name Choose Address 1 First, last name (postal address in Switzerland mandatory) click here if same as 1a): Address 2 Zip Code Address 1 City Address 2 Email Zip Code Telephone Email Telephone 2) Principal Investigator (PI, in multicenter studies: Coordinating Investigator CI) Click here if same as 1a): City 6) Local Investigator in multicenter studies list one per center. click here if same as PI: a) First, last name Position, e.g. chief of service Address 1 Address 2 Zip Code City Email Telephone Name of Center First, Last name Address 1 Address 2 Zip Code City Email Telephone 3a) Sponsor, Click here if same as PI or CI: b) First, last name Address 1 Address 2 Zip Code City Email Telephone Name of Center First, Last name Address 1 Address 2 City Zip Code Email Telephone 3b) Sponsor's representative in Switzerland additional local Invesitgators, use Appendix Click here if same as 3a): First, last name Address 1 Address 2 Zip Code City Email Telephone www.swissethics.ch version 1.12, 15.04.2014 5 von 7 AGEK Arbeitsgemeinschaft der Schweizerischen Ethikkommissionen für die Forschung am Menschen Communauté de travail des Commissions Suisse d’éthique pour la recherche sur l'être humain CT CER Signatures By signing below, you will be reaffirming that you understand your role in this project and that you agree with this application and its content. PI (in multicenter studies: CI) Sponsor CRO, if applicable Signature First/Last Name Address Additional documents Depending on the type of submission, additional documents need to be submitted, see: http://www.swissethics.ch/templates.html www.swissethics.ch version 1.12, 15.04.2014 6 von 7 AGEK Arbeitsgemeinschaft der Schweizerischen Ethikkommissionen für die Forschung am Menschen Communauté de travail des Commissions Suisse d’éthique pour la recherche sur l'être humain CT CER Appendix additional local Investigators (One local Investigator per participating center) c) Name of Center g) Name of Center First, Last name First, Last name Address 1 Address 1 Address 2 Address 2 Zip Code City Zip Code Email Email Telephone Telephone d) h) Name of Center City Name of Center First, Last name First, Last name Address 1 Address 1 Address 2 Address 2 Zip Code City Zip Code Email Email Telephone Telephone e) i) Name of Center City Name of Center First, Last name First, Last name Address 1 Address 1 Address 2 Address 2 Zip Code City Zip Code Email Email Telephone Telephone f) Name of Center j) City Name of Center First, Last name First, Last name Address 1 Address 1 Address 2 Address 2 Zip Code City Zip Code Email Email Telephone Telephone www.swissethics.ch version 1.12, 15.04.2014 City 7 von 7 AGEK Arbeitsgemeinschaft der Schweizerischen Ethikkommissionen für die Forschung am Menschen Communauté de travail des Commissions Suisse d’éthique pour la recherche sur l'être humain CT CER Appendices: List of submitted Documents Base form, dated and signed Study protocol, dated and signed Protocol modification, dated and signed Summary of study protocol in current (lay) language Patient information form Patient consent form The Patient Information and Consent Forms are in: French Italian English German Other languages Advertisements and similar materials used in recruitment Information on payment of study subjects, including reimbursement for expenses Information on payment of Investigators Copy of study insurance policy Copies of contracts between the promoter(s) and investigator(s), including all contract research organizations involved in the research Curriculum vitae of the principal investigator Curriculum vitae of co-investigators List of other investigators and collaborators implicated in the study within the jurisdiction of the EC Scientific Literature « Investigator’s Brochure » Correspondence, minutes, and decisions of other Ethical committees Good Clinical Practice certificate Other documents Please list "other documents" here: www.swissethics.ch version 1.13, 21.04.2014 appendix 1
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