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Description
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)
Q&A #78 with Dr
* Prescribing medications based solely on an electronic medical questionnaire constitutes the failure to practice medicine with that level of care, skill, and treatment which is recognized by reasonably prudent physicians as being acceptable under similar conditions and circumstances, as well as prescribing legend drugs other than in the course of a physicians professional practice
It can be injected near the injury site for targeted healing
Desiccants can mitigate humidity effects when proper refrigeration is unavailable
