Abstract:
OBJECTIVE To construct a new information management model for drug clinical trial pharmacy, improve the efficiency of pharmacy operation, and provide reference for other drug clinical trial institutions.
METHODS The workflow of investigational products management was evaluated, the informatization needs of clinical trial pharmacy were analyzed, the informatization platform was established and the efficiency of investigational products management was compared before and after the informatization.
RESULTS The project information file was established at the project approval stage on the information platform by taking each clinical trial project as individual unit. After the start of the project, the whole process of drug receipt, warehousing, distribution/recovery and return were recorded electronically to realize pharmacy inventory, expiration warning, prescription review and other functions. Under the information management model, the time required for each step of pharmacy workflow was significantly reduced, work efficiency and service ability had been effectively improved, data traceability was enhanced, and the frequency of error events associated with drug records were significantly decreased.
CONCLUSION The pharmacy information platform designed based on centralized management can meet the management and supervision needs of investigational drugs at all stages of clinical trials, make the application of investigational drugs more standardized, ensure the drug use safety on subjects, and improve the quality of drug clinical trials.