NIS Considerations – Australia (2017)

£200.00

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

  • Title: NIS Considerations – Australia (2017)
  • Publication Date: 27 Nov 2017
  • No. of Pages: 26
  • Format: PDF
  • Author/ Editor: Stuart McCully

Description

NIS Considerations – Australia

 

This 26-page report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Australia.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmap for Company-Sponsored Post-Marketing Studies
    • HREC Considerations
    • Differentiation Between Single Ethical Review and Multiple Ethical Review Process
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
  • STUDY CONDUCT CONSIDERATIONS
    • Considerations for Competent Authority, HREC 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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