於港大/瑪麗醫院進行臨床試驗的研究藥物均由港大臨床試驗中心研究藥劑中心及瑪麗醫院臨床研究藥房根據SOPs中央管理。
兩項設施均是專為管理臨床試驗的研究藥物而設的設施。這些設施均受嚴格監控,只有獲授權的藥劑師、配藥員及研究藥物管理人員才有權進入。冷藏櫃均配有溫度記錄儀進行監察,並設有緊急後備電力,以及全天候監控及警報系統。所有研究藥物均儲存於被雙重上鎖、溫度受控制的環境中。
設施/能力 | PHAM | CTP |
---|---|---|
門卡出入管制 | ||
雙重上鎖儲存 | ||
溫度受控的儲存環境 | ||
已較準的溫度監控儀監控室溫及冷凍儲存 | ||
4°C的藥物冷藏櫃 | ||
-20°C的藥物冷藏櫃 | ||
-80°C的藥物冷藏櫃 | ||
藥物冷藏櫃設有緊急後備電力                                                          | ||
藥物冷藏櫃備有24小時監控及警報系統 | ||
全面追蹤研究藥物及控制庫存 | ||
完善SOPs |
于港大/玛丽医院进行临床试验的研究药物均由港大临床试验中心研究药剂中心及玛丽医院临床研究药房根据SOPs中央管理。
两项设施均是专为管理临床试验的研究药物 而设的设施。这些设施均受严格监控,只有获授权的药剂师、配药员及研究药物管理人员才有权进入。冷藏柜均配有温度记录仪进行监察,并设有紧急后备电力,以及全天候监控及警报系统。所有研究药物均储存于被双重上锁、温度受控制的环境中。
设施/能力 | PHAM | CTP |
---|---|---|
门卡出入管制 | ||
双重上锁储存 | ||
温度受控制的储存环境 | ||
已较准的温度监控仪监控室温及冷冻储存 | ||
4°C的药物冷藏柜 | ||
-20°C的药物冷藏柜 | ||
-80°C的药物冷藏柜 | ||
药物冷藏柜设有紧急后备电力                                                          | ||
药物冷藏柜备有24小时监控及警报系统 | ||
全面追踪研究药物及控制库存 | ||
完善SOPs |
Study drugs for clinical trials conducted in HKU/QMH are jointly managed by QMH’s Clinical Trials Pharmacy (CTP) and HKU-CTC’s Research Pharmaceutical Core in accordance with their SOPs.
Both facilities are for study drug management for clinical trials. They are strictly-controlled units accessible only to authorized pharmacists, dispensers and study drug management personnel. All study drug refrigerators are monitored by temperature data loggers and supported by emergency electricity backup and round-the-clock monitoring and alarm system. All study drugs are stored in double-locked, temperature-controlled environment.
Facility/Capability | PHAM | CTP |
---|---|---|
Card access control | ||
Double-locked storage | ||
Temperature-controlled storage environment | ||
Calibrated temperature monitors for ambient and refrigerated storage | ||
4°C drug refrigerators | ||
-20°C drug freezers | ||
-80°C drug freezers | ||
Emergency electricity backup for drug refrigerators | ||
24-hour monitoring and alarm system for drug refrigerators | ||
Full study drug tracing and inventory control | ||
Comprehensive standard operating procedures |