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Study Drug Management

Study drug quality is a key to ensuring data integrity in clinical drug trials and protecting subjects’ safety. Maintenance of good study drug quality at study sites relies on professional study drug management and proper drug accountability – before, during and after each clinical study.

HKU-CTC provides a full range of study drug management services through its Study Drug Management Unit (SDMU) and in collaboration with QMH’s Clinical Research Pharmacy (CRP). Professional pharmacists, dispensers and study drug management personnel from the two units jointly perform study drug management by using their dedicated, well-maintained equipment and in strict compliance with their SOPs. All study drug movements are closely traced and fully documented in study drug accountability records.

Facility/Capability SDMU CRP
Professional consultation on study drug management
Study drug receipt
Study drug labelling
Study drug storage in ambient and at 4°C
Study drug storage at -20°C  
Study drug randomization  
Study drug reconstitution  
Study drug transfer to study sites
Study drug dispensing to subjects  
Study drug disposal  
Study drug accountability and inventory control
Comprehensive SOPs

Being licensed as an authorized chemical waste producer by the Hong Kong Environmental Protection Department (EPD), HKU-CTC is also able to help study sites and sponsors to properly dispose of expired, unused, remaining and returned study drugs in full compliance with local regulations through its MedDrop service. All study drugs pending for disposal are temporarily stored in HKU-CTC’s dedicated Study Drug Disposal Depot (SDDD). The whole drug disposal process is supported by complete documentation on study site level. MedDrop service is not only available to HKU/QMH but also to study sites anywhere in Hong Kong.

Highlights
Dedicated Study Drug Disposal Depot (SDDD)
Holder of Waste Producer Licence required for disposal of study drugs
Comprehensive SOPs
Full compliance with local regulations on chemical waste disposal
Disposal and destruction through dedicated chemical waste handling company qualified by the Hong Kong EPD
Complete disposal documentation on individual study site level
Service available to study sites anywhere in Hong Kong