NIS Considerations – Portugal (2018)

£200.00

 

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

  • Title: NIS Considerations – Portugal (2018)
  • Publication Date: 30 Sep 2018
  • No. of Pages: 15
  • Format: PDF
  • Author/ Editor: Patricia Garcia

Description

NIS Considerations – Portugal

 

This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Portugal.  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:
    • Regulatory Roadmaps:
      • Mandated PASS Portugal Only
      • Mandated PASS International
      • Other Non-Interventional Studies
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Annotated Ethic Committee Submission Checklist
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
    • Organization of Ethics Committees
  • STUDY CONDUCT CONSIDERATIONS
    • Considerations:
      • Ethics Approval, Contract Management, Informed Consent Requirements, 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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