薬理と治療

Abstract

Clinical data managers are categorized as central data managers and site data managers, depending on their affiliation. We defined the roles that each carries and we thought that they can contribute to securing the quality of clinical research by understanding each other’s roles and taking cooperation. The central DM builds a process that can collect accurate and clean data, and the Site DM builds a process to report accurate and clean data from the facility. By carrying out tasks according to the process each constructed, it is possible to secure a predetermined quality. As one of the ingenuity for that, we propose to share the data management plan and procedures and use it as a communication tool.