Study drugs for clinical trials conducted in HKU/QMH are centrally managed by HKU-CTC’s Study Drug Management Unit (SDMU) and QMH’s Clinical Research Pharmacy (CRP) in accordance with their SOPs.
Both SDMU and CRP 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.
|Card access control|
|Temperature-controlled storage environment|
|Calibrated temperature monitors for ambient and refrigerated storage|
|4°C drug refrigerators|
|-20°C drug refrigerators|
|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|