一、“制度建设”的范畴与分类1.广义的“制度建设”可能包括:制度、SOP、章程、职责、设计规范、工作指引等。2.SOP的分类一般有:工作程序类:如“药物接受、储存、分发、使用…的SOP”;专项管理类:如“院外CRC聘请、使用与管理的SOP”;设备操作类等。二、制度建设的一般原则1.制度/SOP的作用包括:建立新的工作秩序、明确工作范畴、规范操作过程、优化工作流程、改进 I. Categories and Categories of “Institutional Construction” 1. Generalized “Institutional Construction” may include: system, SOP, charter, duties, design specifications, working guidelines, etc. 2. The general classification of the SOP are as follows: Work procedures: such as “SOP ” for the acceptance, storage, distribution and use of drugs; special management categories such as “SOP” for hiring and using CRC outside the hospital; Class and so on. Second, the general principles of system construction 1 system / SOP’s role include: the establishment of a new work order, a clear scope of work, regulate the operation process, optimize the workflow, improve