NIS Considerations – Czech Republic (2015)

£200.00

This short 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 (2015)
  • Publication Date: 03 September 2015
  • No. of Pages: 31
  • Format: PDF
  • Author/ Editor: Stuart McCully

Description

NIS Considerations – Czech Republic

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

  1. REGULATORY BODIES
  2. SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    1. Regulatory Roadmap for Single-Country NIS
    2. Regulatory Roadmap for Multi-Country NIS
    3. Regulatory Roadmap for Single-Country Mandated PASS
    4. Regulatory Roadmap for Multi-Country Mandated PASS
  3. REGULATORY SUBMISSIONS DOCUMENTS
    1. REC Submissions Document Checklist
    2. SUKL Submissions Checklist
    3. Which Documents Need to Be Translated?
    4. Who Is Responsible for What?
  4. STUDY CONDUCT CONSIDERATIONS
  5. APPLICABLE LEGISLATION AND GUIDELINES
  6. USEFUL LINKS
    1. Regulatory Requirements
    2. Data Privacy Considerations
    3. Study Conduct Considerations
    4. Human Tissue Research and Genetic Research Considerations
    5. Best Practice Considerations

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