| 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 Leads | Emails |
|---|---|
Chris Smith, FDA | christopher.smith2@fda.hhs.gov |
Charles Beasley, Medical | |
| Nicola Newton, PHUSE Project Assistant | nicky@phuse.global |
| Objectives and Deliverables | Timetables |
|---|---|
| White Paper (TBC) | Ongoing |
| Determined focal topics for an interactive laboratory displays specific document that are common in safety exploration and decision making amongst various stakeholders. Q4 2024 | ||||||
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