NIS Considerations – Switzerland (2018)

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This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies (NIS) in Switzerland.

  • Title: NIS Considerations – Switzerland (2018)
  • Publication Date: 10 August 2018
  • No. of Pages: 32
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-CH-2015 Categories: , , Tags: ,

Description

NIS Considerations – Switzerland

This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Switzerland.  All sources of information are referenced and hyperlinked.  Topics covered include:

  1. REGULATORY BODIES
  2. SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    1. SWISS ORDINANCES ON RESEARCH WITH HUMAN BEINGS AND HEALTH-RELATED DATA
    2. RESEARCH CATEGORIES
    3. REGULATORY ROADMAP FOR HFV RESEARCH (MULTI-CENTER STUDIES)
    4. REGULATORY ROADMAP FOR HFV RESEARCH (SINGLE STUDY CENTER IN SWITZERLAND)
  3. REGULATORY SUBMISSIONS DOCUMENTS
    1. REQUIRED DOCUMENTS / INFORMATION FOR NON-CLINICAL RESEARCH PROJECTS
    2. REQUIRED DOCUMENTS / INFORMATION FOR LOCAL SITES IN MULTICENTRIC STUDIES
    3. WHICH DOCUMENTS NEED TO BE TRANSLATED?
    4. WHO IS RESPONSIBLE FOR WHAT?
    5. REORGANIZATION OF ETHICS COMMITTEES
  4. STUDY CONDUCT CONSIDERATIONS
  5. APPLICABLE LEGISLATION AND GUIDELINES
  6. USEFUL LINKS
    1. REGULATORY REQUIREMENTS
    2. DATA PRIVACY CONSIDERATIONS
    3. STUDY CONDUCT CONSIDERATIONS
    4. BEST PRACTICE CONSIDERATIONS
  7. DOCUMENT HISTORY

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