The Status Survey On The Management Mode Of Investigational Products And The Analysis Of The Existing Problem

Objective:We conducted a survey to investigate the current situation of management of Investigational products in a total of 42 drug clinical trial institutions in Guangdong Province. In addition, completed clinical trial reports were retrospectively analyzed to identify problems of management of investigational products in a specific clinical trial institution.Method:1. A questionnaire survey was conducted to investigate the current management situation of investigational product in Guangdong Province. The questionnaire focus on: management mode, systems and training, storage facilities, the procedures of management, quality controls and emergency response plan.2. Problems of management of investigational products were analyzed using 32 completed clinical trial reports from a specific clinical trial institution in Guangdong Province. Those report were completed when investigational products were managed by clinical department(21 clinical trials), or by GCP central pharmacy(11 clinical trials). Problems with investigational product management were identified, reasons were discussed, and advices to solve those problems were given.Results:1. A total of 38 questionnaires were analyzed. Investigational products were managed by clinical department(CD)(22 institutions), GCP central pharmacy(GCP-CP)(12 institutions),and pharmacy department(PD)(4 institutions). There is no difference in systems and training among three modes(p>0.05). CP and PD have dedicated space, special medical cabinets, safety measures in terms of storage of investigational product,half of the institutions do not have over-temperature alarm system. Temperature and humidity were recorded differently among three modes(p<0.05). Most of the investigational product managers comply with relevant provisions of the laws and regulations, SOP and scheme.2. More problems were identified when investigational products were managed by clinical department than by GCP clinical pharmacy(1001 vs 246). Common problems were distribution/recovery of investigational product, prescription and storage. The reasons of existing problems were analyzed in the management of investigational product, and countermeasures were put forward.Conclusion: Clinical department management of investigational product is the primary mode in Guangdong. There are differences among three modes. After the implementation of GCP central pharmacy in a specific institution, problems of management of investigational product weresignificantly reduced. This mode has certain advantages. Institutions should choose their own management modes according to numbers of certified professionals, numbers of projects, hospital’s hardware facilities.