NIS Considerations – Switzerland (2019)

£200.00

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

  • Title: NIS Considerations – Switzerland (2019)
  • Publication Date: 23 Jan 2019
  • No. of Pages: 27
  • Format: PDF
  • Author/ Editor: Mark Heinemann
SKU: NIS-C-CH-2019 Categories: , , Tags: ,

Description

NIS Considerations – Switzerland

 

This 27-page 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:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Submission Roadmaps for Observational Studies:
      • Differentiation of Research Categories
      • Regulatory Roadmap for HFV Research (Multi-Center Studies)
      • Regulatory Roadmap for HFV Research (Single Study Center in Switzerland)
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Required Documents / Information for Non-Clinical Research Projects
    • Required Documents / Information for Local Sites in Multi-centric Studies
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
    • Organization of Ethics Committees
    • BASEC Process
  • STUDY CONDUCT CONSIDERATIONS
    • Considerations:
      • Swissmedic Notification for Class A Research
      • Ethics Approval, Insurance for Non-Interventional Research, Contract Management, Safety Reporting, Study Amendments, Study Progress Management, End of Study Requirements and More
      • Consent Guidance
  • APPLICABLE LEGISLATION AND GUIDELINES
  • USEFUL LINKS
    • Regulatory Requirements
    • Study Conduct Considerations
    • Data Privacy Considerations
    • Human Tissue and Genetic Research Considerations
    • Best Practice Considerations

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