NIS Considerations – United Kingdom (2018)

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

  • Title: NIS Considerations – United Kingdom (2018)
  • Publication Date: 16 Nov 2018
  • No. of Pages: 41
  • Format: PDF
  • Author/ Editor: Stuart McCully / Patricia Garcia

Description

NIS Considerations – United Kingdom

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmaps and Summary of Regulatory Requirements in England, Wales, Scotland and Northern Ireland
    • Regulatory Roadmaps for Prospective Non-Interventional Studies and Voluntary Post-Authorization Safety Studies (PASS)
    • Regulatory Roadmaps for Mandated PASS (UK Only) and Multi-Country Mandated PASS (International)
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist HRA/HCRW Approval in England and Wales
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
  • STUDY CONDUCT CONSIDERATIONS
    • Study Conduct Considerations for England, Wales, Scotland and Northern Ireland
    • Considerations for HRA 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
  • Annex
  • Research in the UK Considerations and Study Classification
  • Clinical Research Networks
  • National Institute for Health Research Clinical Research Network
  • HRA and HCRW Approval Process
  • NHS Site Set-Up in England and Wales
  • IRAS Application

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