NIS Considerations – Czech Republic (2017)

£200.00

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

  • Title: NIS Considerations – Czech Republic (2017)
  • Publication Date: 06 Jul 2017
  • No. of Pages: 25
  • Format: PDF
  • Author/ Editor: Mirela Tudor

Description

NIS Considerations – Czech Republic

 

This 25-page report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in the Czech Republic.  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:
      • Non-Interventional Studies
      • Non-Interventional PASS
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist for ECs and SUKL
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
  • STUDY CONDUCT CONSIDERATIONS
    • Considerations: Competent Authority, Ethics Approval, Contract Management, Consent, Safety Reporting, Study Amendments, Study Progress Management, End of Study Requirements and More
  • 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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