Taniguchi M.,Public Interest Incorporated Foundation |
Nakabayashi M.,Bell Medical Solutions Inc. |
Oshiba I.,MD and R Corporation |
Sugihara S.,EPS Assoct. Corporation Ltd. |
And 3 more authors.
Japanese Journal of Clinical Pharmacology and Therapeutics | Year: 2015
In April 2012, the Chiken(clinical study for drug application)Promotion Committee of Osaka Pharmaceutical Manufacturers Association(OPMA)and Osaka Clinical Research Collaborative Network(OCRCN)organized three Working Groups(WG)composed of clinical research coordinators(CRCs)and clinical research associates(CRAs) to discuss the improvement of the efficiency of Chiken execution. Each group had regular monthly meetings for one and a half years. The firstWG focused on the current understanding and treatment of "source data/document. " It is revealed that a so-called "work sheet" is widely used to record clinical data/comments in Chiken;data /comments are directly recorded on Case Report Forms(CRFs)only in around 50% of the cases. The second WG focused on the method to develop a more intelligible protocol in order to avoid misunderstanding of a protocol by clinical trial sites. It is agreed that a protocol should be developed that further reflects the actual work process of Chiken in a clinical site, and that more detailed explanations of the execution process in a protocol should be helpful. The third WG focused on "standardization of checklist for both clinical sites and study sponsors", covering the selection of clinical trial sites and execution of clinical trial agreements. It is also recognized that the checklist, apart from the original purpose of increasing the efficiency of the execution of clinical trials, is expected to be used as a training tool for beginners. After completing all tasks, a survey was made to assess this activity. Most of the members expressed positive opinions on this project, and the activity to develop a standardized checklist is on-going. © 2015 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT).