NIS Considerations – Vietnam (2015)

£200.00

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

  • Title: NIS Considerations – Vietnam (2015)
  • Publication Date: 02 September 2015
  • No. of Pages: 12
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-VN-2015 Categories: , , Tag:

Description

NIS Considerations – Vietnam

This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Vietnam.  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 all NIS
  3. REGULATORY SUBMISSIONS DOCUMENTS
    1. EC Submissions Document Checklist
    2. LEC Submissions Document 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. Study Conduct Considerations
    3. Best Practice Considerations
    4. Human Research Considerations
    5. Data Privacy Considerations

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