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Project scope

Interactive Analyses and Displays of laboratory data, applicable to Phase 2-3 clinical trials and integrated submission documents. Creating interactive analyses and displays would allow more options for the user without adding substantial volume and would provide a more user-friendly method for reviewing laboratory data. Multiple groups are involved in creating interactive displays or tools for clinical trial data, and having a deliverable outlining the desired features, with associated education on interpreting the analyses/displays, would help progress the overall efforts.



Project LeadsEmails

Chris Smith, FDA

christopher.smith2@fda.hhs.gov

Charles Beasley, Medical

charlesmbeasleyjr@msn.com

Nicola Newton, PHUSE Project Assistantnicky@phuse.global 



Objectives and DeliverablesTimetables
White Paper (TBC)Ongoing



Status
colourBlue
titleCurrent Status
Q2 2024

  • Determined focal topics for an interactive laboratory displays specific document that are common in safety exploration and decision making amongst various stakeholders.