Recent additions / changes

DateDocument
November 28, 2016New version (2.0) : Template for the Declaration of consent (studies with children and adolescents), in German: .pdf, .docx
November 2nd, 2016New document (v1.0): Notification of significant changes and other changes to the ethics committee for clinical trials (ClinO) and for research projects not involving clinical trials (HRO): .pdf
October 18, 2016New template (v1.0): Template for drafting an Annual Safety Report for Investigator initiated trials’ (IITs) in accordance with the Ordinance on Clinical Trials (ClinO): .pdf, .docx
October 5, 2016New template (v1.0): Template for the notification of serious events (SE) to the ethics committees for research projects not involving clinical trials (HRO): .pdf, .docx
September 9, 2016New document (v1.0): What if an Investigator of an ongoing clinical trial is absent for an extended period of time? How should this be handled? .pdf

Templates

Please always download and use the latest version of the templates.

  • Information about and template for the synopsis of the study protocol: .pdf, .docx
  • Templates for study protocols
    • Clinical trials: .pdf, .docx
         -->Guideline and reminder for Swiss specific requirements in study protocols:
         -->.pdf
    • Human research other than clinical trials: .pdf, .docx
    • Template for the submission of a project "further use without consent" according to HRA Art.34/HRO (in German): .pdf, .docx. The use of the template is mandatory.
    • Template for the submission of a project "further use with consent" according to HRA/HRO (in German): .pdf, .docx. The use of the template is mandatory.
  • Patient information and Declaration of consent / biobank regulations
    • Clinical Trials (ClinO)
      • swissethics-template for drafting information for participants in studies involving humans in accordance with the Human Research Act (HRA) and the Ordinance on Clinical Trials (ClinO), in German (English version not available at the moment): .docx, .pdf
    • HRO with persons (HRO chap. 2)
      • swissethics-template for HRO with persons, according to HRA/HRO chapter 2 (not: ClinO or HRO chapter 3 "further use"). In German, versions in French and Italian available in the according language sections of swissethics.ch.
        .docx, .pdf
    • Further use of biological material and personal data (HRO chap. 3)
      • Art. 28 HRO: Information document about the re-use of unencoded biological material and genetic data for a research project: .docx, .pdf
      • Art. 29 HRO: re-use of encoded biological material and medical data for a research project: .docx, .pdf
      • Art. 31 HRO: re-use of medical (non-genetic) personal data for research purposes in unencoded form: .docx, .pdf
    • Biobanks
      • Information / declaration of consent: The templates in this folder for the information/declaration of consent are valid till the implementation of the new General Consent (presumably 1Q17).
        • Template for the information / Declaration of consent for the further use/use of biological material and health-related data: .docx, .pdf
        • Template for the information / Declaration of consent in case of additional procedures (blood sampling etc.) art. 8, HRO: .docx, .pdf
      • Swissethics Guide for the preparation of biobank regulations in connection with research projects involving human beings: .docx, .pdf
      • Template for Biobank regulations in connection with research projects involving human beings: .docx, .pdf
  • Research on and with children
    • Checklist: Research on and with children and adolescents under the age of 18: .pdf
    • Guidelines for the provision of study information: .docx, .pdf
    • Template for the Declaration of consent: (Studies with children and adolescents), in German: .pdf, .docx
  • Research in an emergency situation
    • Guide to research in an emergency situation (HRA art. 30-31; ClinO art. 15-17; HRO art. 11), in German: .pdf
    • Schriftliche Bestätigung durch einen nicht am Versuch beteiligten Arzt, der/die nicht in die nachstehend genannte Studie involviert ist und unter Wahrung der Interessen der Versuchsperson deren medizinische Betreuung sicherstellt (HFG art 30): .pdf, .docx
  • Recruitment of study participants by means of advertising
    • Checklist for the recruitment of study participants by means of advertising: .pdf
    • Specimen text for advertisement: .docx  .pdf
  • Insurance
    • General Insurance Conditions (GIC) for clinical trials in Human Research: .pdf
    • General Insurance Conditions (GIC) for non-clinical research projects pursuant to the Human Research Ordinance (HRO): .pdf
    • Insurance (template) for clinical trials (valid for medicinal products, transplant products, medical devices and other clinical trials): .pdf, .docx
    • Insurance (template) for sampling of biological material and collection of health-related personal data (within the scope of research projects that do not qualify as clinical trials): .pdf, .docx
    • Certificate of security in lieu of and equivalent to liability insurance: .pdf, .docx
    • Obligations of representatives of foreign sponsors: .pdf
  • Clinical Study Agreement: Template for the clinical study agreement: .docx, .pdf
  • Staff list: .docx  .pdf
    -->Note: The ‘Staff list’ should be used in accordance with the Ordinance on Clinical Trials (ClinO) Annex 3 (1.10, 2.11, 3.9, 4.4) and with the Ordinance on Human Research with the Exception of Clinical Trials (HRO) Annex 2 (1.8, 5.11, 7.9). The ‘Staff list’ is not to be confused with the ‘delegation log’ as per ICH-GCP E6 4.1.5.
  • Suitability and availability of infrastructure at the research site: .pdf, .docx
  • Reference table of required documents for each type of project: .pdf.
    Note: the online form will automatically determine which documents need to be provided.
  • Archives
    • Checklists for application documentations (ClinO/HRO)
      Note: these checklists are only available for reference and amendments to projects that were initially submitted outside of BASEC. They are no more needed for the submission of new projects.
      • ClinO
        • Application documentation for category A clinical trials involving therapeutic products and transplant products: .pdf, .docx
        • Application documentation for category B and category C clinical trials involving therapeutic products and transplant products: .pdf, .docx
        • Application documentation for clinical transplant trials and for clinical trials that do not involve therapeutic products: .pdf, .docx
        • Application documentation for participating ethics committees in case of multi-centre clinical trials: .pdf, .docx
      • HRO
        • Application documentation for human research projects involving the sampling of biological material or the collection of health-related personal data: .pdf, .docx
        • Application documentation for research projects involving the further use of biological material or health-related personal data: .pdf, .docx
        • Application documentation for research projects involving deceased persons: .pdf, .docx
        • Application documentation for research projects involving embryos and foetuses after abortions or miscarriages (including stillbirths): .pdf, .docx
        • Application documentation for the further use of biological material or health-related personal data in case of lack of consent and information according to Article 34 HRA: .pdf, .docx
        • Application documentation for participating ethics committees in case of multi-centre research projects: .pdf, .docx

Procedures

  • Multicentre studies: concept for a simplified procedure, (in German)
  • Clarification of responsibility for multicentre studies: procedure
  • Case studies. Basic information on real human research projects.
  • Coding of trial subject accepted by swissethics: .pdf
  • Decision letter template (not formatted, in German): .docx, .pdf
  • Template: comment from local EC (multicentre studies, in German): .docx
  • Example of a positive statement for a research project that will be carried out abroad
  • Information exchange ECs/Swissmedic (in German)
  • Scale of fees:
    • Starting 1Q17 all ethics committees will charge using the scale of fees of April 19, 2014 (updated on August 16, 2016).
    • Scale of fees before 2017:
      • The scale of fees of April 19, 2014 (updated on August 26, 2015/February 22, 2016) is currently used by the ethics committees Zurich, Vaud, Ticino and by EKNZ (in German): .pdf
      • The scale of fees of April 19, 2014 (updated on August 16, 2016) is currently used by the ethics committees Bern, Geneva and by EKOS (in German and French): .pdf
  • Definition of response times (in German): .pdf
  • Scientific secretariat: Function and job description: .pdf
  • Template for the notification of serious events (SE) to the ethics committees for research projects not involving clinical trials (HRO): .pdf, .docx
  • Template for drafting an Annual Safety Report for Investigator initiated trials’ (IITs) in accordance with the Ordinance on Clinical Trials (ClinO): .pdf, .docx
  • Notification of significant changes and other changes to the ethics committee for clinical trials (ClinO) and for research projects not involving clinical trials (HRO):
    .pdf
  • Notification and reporting to the ethics committee for clinical trials (ClinO) and for research projects not involving clinical trials (HRO): .pdf, .docx
  • Absence of the investigator for an extended period of time? How should this be handled? .pdf
  • Protocol violations, changes in protocols and safety measures: .pdf (in German)
  • Template for closing report to the research ethics committee: .pdf, .docx

Position papers / Guidelines

  • Monetary contributions to patients participating in research projects, an ethically justified guide
    (in German): .pdf
  • Experimental therapy versus research projects under obligation of submission
    to an EC (in German): .pdf
  • swissethics guideline: research projects in neuroscience (in German): .pdf
  • Position paper of swissethics on the standardisation of working processes of ECs (in German): .pdf

Recommendations

Categorization

  • Categorisation of studies involving therapeutic products: Advice/recommendations by Swissmedic on MB Information Sheet FAQ under point 3.
  • Categorisation of placebo controlled studies:
    The website KOFAM provides a tool for assessing the category of a trial. The RECs (not Swissmedic) are responsible to check if the category is correct.
    See also (Click: guidelines for CTA dossiers submitted > BW101_10_004e_AL Guideline Clinical Trial Application Dossier. Of interest: section 7 und 8.)
  • Reclassification of clinical trials with medicinal products authorized under the previous law (art. 71 ClinO), in German: .pdf