Project Scope
This project team will create a users guide or White Paper with recommendations for analysis and displays for Laboratory Data, with a focus on Phase 2-4 clinical trials and integrated submission documents. There have been 2 previous White Papers on this topic (1 for central tendency in 2013 and 1 for Outliers/Shifts in 2015). This paper will combine two method types and update recommendations given the advancement in interactive options.

Project Scope

This project team will create a users guide or White Paper with recommendations for analysis and displays for Laboratory Data, with a focus on Phase 2-4 clinical trials and integrated submission documents. There have been 2 previous White Papers on this topic (1 for central tendency in 2013 and 1 for Outliers/Shifts in 2015). This paper will combine two method types and update recommendations given the advancement in interactive options.

Project Leads	Email
Charles Beasley, Beasley Pharmaceutical and Biotechnology Consulting	charlesmbeasleyjr@msn.com
Christopher Smith, FDA	christopher.smith2@fda.hhs.gov
Nicola Newton, PHUSE Project Assistant	nicky@phuse.global

CURRENT STATUS Q3 2023
Project Closed.

Objectives & Deliverables	Timelines
Align on next steps	Q2 2023

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