
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物管理部及瑪麗醫院臨床研究藥房根據SOPs中央管理。
研究藥物管理部及臨床研究藥房是專為管理臨床試驗的研究藥物而設的設施。這些部門均受嚴格監控,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有關設施。冷藏櫃均配有溫度記錄儀進行監察,並設有緊急後備電力、無間斷能源供應,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及無間斷能源供應                                                          | ||
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物管理部及玛丽医院临床研究药房根据SOPs中央管理。
研究药物管理部及临床研究药房是专为管理临床试验的研究药物 而设的设施。这些部门均受严格监控,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有关设施。冷藏柜均配有温度记录仪进行监察,并设有紧急后备电力、无间断能源供应,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及无间断能源供应                                                          | ||
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 centrally managed by HKU-CTC’s Study Drug Management Unit (PHAM) and QMH’s Clinical Trials Pharmacy (CTP) in accordance with their SOPs.
Both PHAM and CTP are dedicated facilities 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, uninterrupted power supply 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 and uninterrupted power supply for drug refrigerators | ||
24-hour monitoring and alarm system for drug refrigerators | ||
Full study drug tracing and inventory control | ||
Comprehensive standard operating procedures |