Versions Compared

Version Old Version 5 New Version 6
Changes made by

Alex Pearce

Alex Pearce

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.


Project Scope 

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

  • Identifying critical items
  • Risk Based Data 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 small studies focus



Project LeadsEmail

Agnes Verhoeven, Johnson & Johnson

Averho10@its.jnj.com

Alicja Budek Mark, Genmab

amar@genmab.com
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 the PHUSE Connect sessionQ1 2025

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

Q2 2025