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Description
Q&A #78 with Dr
Always verify
Desiccants can mitigate humidity effects when proper refrigeration is unavailable
A PI should enforce an escalation ladder: Tier 1 (Same day): notify PI + document immediate actions Tier 2 (2448h): sponsor medical monitor/PV + corrective steps Tier 3 (within a week): systemic CAPA, retraining, process change, monitoring focus shift This ladder must tie into PV structure (pharmacovigilance essentials) and monitoring accountability (CRA responsibilities)
