Description:
User observed that some Day 1 lab values expressed as multiples of upper limit of normal (xULN) are not 0, suggesting Day 1 may not represent true baseline. Questions raised:
- Are Day 1 values the true baselines?
- Were earlier screening baselines used instead?
- What are the true baselines for all labs and their corresponding study days?
Action Items:
Additional Context:
This could indicate a fundamental issue with how baseline values are identified or calculated in the application.