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Project Scope 

To discuss and focus on a robust strategy/process and best practises for

  • Identifying critical items
  • Risk Based Data review approaches
  • Risk Based Monitoring approach strategy (tSDV/tSDR),
  • Usage of analytical tools and methods for data review & central monitoring, including limitations on (statistical) methodologies,
  • Identification of thresholds or equivalent on limited patient data
  • Targeted medical review
  • Strategy to adequately anticipate on highly dynamic dataEstablish links with the other work streams on FIH/Small studies focus



Project LeadsEmail

Agnes Verhoeven, Johnson & Johnson

Averho10@its.jnj.com

Marijke Gyselinckx, Johnson & Johnson

Alicja Budek Mark, Genmab

amar@genmab.comTBCTBC
Alex Pearce, PHUSE Project Assistant

alexandra@phuse.global


Status
colourBlue
titleCurrent Status
Q2 2024

  • New project approved currently calling for volunteers 



Objectives Timelines
Present at Phuse Connect sessionQ1 2025

White paper or guidance document with a mutual agreed process for RBQM on FIH/Small studies

Q2 2025