目的：臨床試驗中若誤用禁用藥物，可能導致試驗違規並影響病人用藥安全。根據臨床試驗指引，應確保臨床試驗品質與用藥管控。本專案旨在建置以受試者為中心的禁用藥物管控系統，強化資訊透明與自動化檢核機制，提升試驗品質與病人安全。方法：運用問題解決型從臨床試驗禁用藥物流程找出7項真因。團隊擬定四大對策群組，包括建置標準作業規範、批次上傳與資料校正、三級風險警示與雙碼比對、個人化管控設定等。結果：改善後，使用禁用藥物導致試驗違規從18件降至0件，禁用藥物建檔率由20%提升至100%，建檔時間由102分鐘縮短至18分鐘。內外部顧客滿意度皆逾九成。結論：專案導入系統化管理與人機互動優化，成效良好推廣至體系醫院共同提升用藥安全。

Objective: Misusing prohibited medications in clinical trials may lead to protocol violations and compromise patient safety. Clinical trial guidelines indicate that ensuring trial quality and medication control is essential. This project aimed to establish a patient-centered prohibited drug management system to improve data transparency, enable automated verification, enhance trial quality, and ensure patient safety. Methods: A problem-solving approach was used to identify seven root causes of prohibited drug processes in clinical trials. Four major countermeasure groups were established: standard operating procedures, batch uploads with data correction, three-level risk alerts with dual-code verification, and personalized control settings. Results: After implementation, the number of protocol violations attributable to prohibited drug use decreased from 18 to 0. The prohibited drug configuration completion rate increased from 20% to 100%, and the average documentation time reduced from 102 to 18 minutes. Both internal and external customer satisfaction exceeded 90%. Conclusion: The proposed system introduces systematic management capabilities and optimizes human–system interaction. Its successful implementation demonstrates strong potential for application across affiliated hospitals to further enhance medication safety.