NIS Considerations – France (2018)

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

  • Title: NIS Considerations – France (2018)
  • Publication Date: 10 Aug 2018
  • No. of Pages: 27
  • Format: PDF
  • Author/ Editor: Mark Heinemann

Description

NIS Considerations – France

 

This 27-page report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in France.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmaps for Non-interventional Studies in the Scope of French Law Decree 2016-1537 “Recherche Impliquant la Personne Humaine” (RIHP)
    • Differentiation between Non-Interventional-, Minimum Risk- and Interventional Research Considering French Law Decrees of 12 April 2018 (New in 2018)
    • Regulatory Roadmaps for Prospective Non-Interventional Studies and Voluntary Post-Authorization Safety Studies (PASS)
    • Regulatory Roadmaps for Mandated PASS (France Only) and Multi-Country Mandated PASS (International)
    • Regulatory Roadmap for Research with Existing Data in France (New in 2018)
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist for Ethics Committees, Competent Authority and Data Protection Authority CNIL
    • Contract Review Modalities of the French Physician’s Council
    • Regulatory Submissions Document Checklist for Retrospective Research with Existing Data
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
  • STUDY CONDUCT CONSIDERATIONS
    • Requirements Related to Competent Authority and Ethics Committees
    • How to Proceed with “MR-003”
    • Investigator Agreement Review (CNOM or CROM?)
    • Considerations for Ethics Approval, Contract Management, Consent, Safety Reporting, Study Progress Management, End of Study Requirements and More
    • Transfer of Value and Financial Disclosure Requirements in France
  • 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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