NIS Considerations – Ireland (2015)

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

  • Title: NIS Considerations – Ireland (2015)
  • Publication Date: 08 June 2015
  • No. of Pages: 11
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-IE-2015 Categories: , , Tags: , ,

Description

NIS Considerations – Ireland

This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Ireland.  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 PRAC Mandated PASS
    2. Regulatory Roadmap for Other NIS
  3. REGULATORY SUBMISSIONS DOCUMENTS
    1. Regulatory Submissions Document Checklist
    2. Which Documents Need to Be Translated?
    3. 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 Considerations
    5. Best Practice Considerations

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