The platform supports decisions. It does not own them.

"Coordinator capacity has fallen below the operational threshold for Visit 4 complexity. No automated support pathway can substitute for protocol-specific clinical judgment in dose adjustment review."

1. B.1Lead coordinator on bereavement leave; backup not credentialed for ATX-3104 amendment v5
2. B.2Amendment v5 introduces concomitant medication review without procedural detail
3. B.3Site IRB queue currently 14 days — exceeds protocol-defined window

"Execution-fit drift detected across three consecutive monitoring visits. Pattern indicates structural friction — not individual coordinator performance — requiring leadership re-scoping rather than additional support tooling."

1. B.1Two concurrent Phase III protocols sharing the same coordinator pool
2. B.2Communication latency with sponsor exceeds 72h on three open queries
3. B.3Training completion for amendment v5 at 41% across active staff

"Operational ambiguity in protocol section 7.3 has produced inconsistent visit-window handling. The platform recommends human clarification rather than auto-mediated workaround."

1. B.1Section 7.3 contains conditional logic without decision tree
2. B.2Two prior queries closed without written sponsor response