Clinical Researchers and Research Teams
Intra-hospital Cross-departmental Units. (Ex:IRB or CTC)
Global Pharmaceutical Companies
Contract Research Organizations (CROs)
Pharmacy Department of the National Cheng Kung University Hospital (NCKUH) was established in June, 1988. The pharmacy division leader joins the Institutional Review Board to serve as a member and participate in review. The clinical trial pharmacists attend site initiation meetings, are responsible for management of investigational product including receipt, storage, dispensing, return, reconciliation, destruction, and accountability. All activities are properly documented and maintained in compliance with Good Clinical Practice (GCP) guidelines.
The services for the management of investigational drugs have achieved a high level of satisfaction among principal investigators, study coordinators, clinical trial associates, and sponsors of the clinical trials. In 2002 and 2015, the practices for the management of investigational drugs were audited by US FDA, and have met the international standards. We are committed to maintaining excellence and adherence to international standards in the management of investigational drugs.
Electronic labeling of non-oncology medications in chemotherapy pharmacy
Implementation of automated computerized storage systems to improve space utilization
Expansion of barcode applications in the chemotherapy pharmacy to include investigational product documentation
More than 120 new protocols are initiated annually.
An average of more than 200 shipments are received per month.
An average of over 100 monitoring visits conducted by CRAs per month.
An average of more than 600 dispensing records are processed per month.
The quality indicator for “near-miss events and dispensing errors related to investigational products” is defined as maintaining a weighted event-free duration of more than 250 days.
An alert system for prohibited concomitant medications in clinical trials, generating more than 100 alerts per month, has been established.
SUSAR cases occurring at our institution are assessed by five dedicated clinical trial pharmacists.
More than 400 expired items are identified during the annual inventory review.
Overall pharmacy satisfaction exceeded 90%, with zero respondents reporting dissatisfaction or strong dissatisfaction.
Our institution successfully achieved AAHRPP full reaccreditation.
A poster was presented at the AAHRPP Annual Conference in the United States in 2024.
Cross-departmental collaboration in the management of investigational products for clinical trials.
Participation in multiple multinational and highly complex clinical trials.
Providing pharmacy students with internship opportunities in the clinical trial pharmacy.
