摘要
中医临床研究过程的每项工作都应根据该研究方案的要求制定相应的标准操作规程(SOP),但有实验室共性SOP和课题特有SOP的区别。后者是研究项目特有的,要根据所研究课题的特点从新制订,是SOP制订的重点。内容制订和格式制订的原则,必须是临床中的操作性要强,要求有详细的操作步骤,以便研究者较好地遵从。有较统一的格式要求,包括封面、目次、前言并且附加说明、正文要求、范围、引用标准、定义等,也可以根据需要对格式进行修改。SOP的制订和执行,可以归纳为通俗的两点:怎么做就怎么写,怎么写就怎么做。如果发现SOP的内容不符合临床研究实际,可以根据研究方案要求进行修改。修订后的SOP,必须按照要求做好记录、存档,按审批程序批准,并对有关参研人员进行培训,认真执行,使修改后的SOP能够真正在研究中施行。
All of the tasks in process of TCM clinical research should base on Standard Operation Procedure（SOP）,however,the subject-specific SOP is different from common laboratory SOP,must be drew up according to the research characteristics.The principles of the content and format should be convenient and comprehensive,in order to abide by researchers.Uniform format requirements including cover,table of contents,preface and notes,requirements,extent,reference standard,definition,etc.At the same time,you can modify the format as required.Formulation and implementation of the SOP can be summarized in two points：the one is operations according to regulations,the other is regulations comply with operations.The SOP should be modified whenever there are unconformities between the contents ofit and actual situation of clinical research.The revised SOP must follow the requirements in record,archive,according to approval procedures,meanwhile conduct staff training to make the modification of the SOP implemented successfully in the clinical research.
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2010年第10期1627-1631,共5页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
"十一五"国家科技支撑计划重大项目资助(No.2006BAI04A21)
"重大新药创制"科技重大专项资助(No.2009ZX09301-005)
第42批中国博士后科学基金资助项目(No.20070420505)
第1批中国博士后特别资助科学基金资助(No.200801167)
中国中医科学院自主选题资助(No.Z02119)~~
关键词
临床试验
中医
标准操作规程
优化
可操作性
执行
修改
Clinical trial
TCM
Standard operating procedure
Optimization
Operability
Implement
Modification
