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LogseqFMS/pages/STOP2030___Viaje a Ghana 20...

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project:: STOP2030 by:: Alejandro Krolewiecki, Marina Gold, Celia Olmos, Alan Brooks date:: 2023/12

  • Entre 2023/12/10 y 2023/12/14
  • Resumen de Alejandro Krolewiecki

    • Participants:
    • To be discussed w ISGlobal and KEMRI
    • WP 2 RDD/Dr Oduro lead from GHS

      • Dates

        • FDC target Oct/Nov, 2024 (early dry season)
        • PZQ - Move to January/Feb 2025 (but at least 3 weeks after FDC)
        • Have FDC available after month 11 sample collection
      • Protocol

        • Protocol ideally finalized in January 2025
          • GHS will wait for detailed review until next version of the protocol
            • Dr. Oduro's team leads review from GHS side
          • Target weeks 8-19 Jan (2 weeks) for review
          • Week 22-26 Jan to incorporate comments by ISGlobal
          • ISGlobal convene virtual discussion on protocol to address emerging/outstanding comments
          • IRB Submissions
            • ISGlobal responsible for submission of documents
            • Ghana submit by 1 Feb in advance of 7 Feb 2024 deadline (5 March as backup)
              • RDD will notify of supporting documents needed for the IRB
        • Training - R&D/ISGlobal
          • Good Clinical Practice (can be GFDA or from different organization as long as not expired)