Preliminary Study Of Establishing Standard Data System Of Clinical Research Of Traditional Chinese Medicine Based On CDISC

Introduction(1) In the real circumstances that the computer and network technology is gradually developing and maturing,research projects are Increasing in their number and the exchanges between International clinical research is more and more frequent, how to improve the quality of clinical research and speed up the process of clinical research is become a focus for clinical research professional. Standardization of clinical research data has restricted the conversion of clinical research and the construction of information technology.Establishing a set of standardized process of clinical research in order to achieve the standardization of data has the important study significance. Clinical Data Interchange Standards Consortium (CDISC) is both Exchange Standard and Analysis Standard. TCM has a larger gap with international advanced levels and their chievement has many objections. The unstandardized clinical research is key reasons. There are many problems need to be solved in the process of comprehensive use of CDISC standards.(2) Case Report Form is an important carrier for Clinical study data collection and only less mportant than program.Throughout CRF in clinical research recent years, there are many problems of its design,which seriously affect the quality of the data thus affect the quality of research.Accompanied by clinical studies advent of electronic clinical systems, more and more people begin to pay attention and try to practice and electronic CRF standardization process.Objective and SignificanceThis paper mainly discribes how to construct the clinical search data of TCM according to CDISC and design the CRF in standardzation,which provides a theoretical basis for clinical search of TCM applying the CDISC standards allsidedly and collecting and managing clinical data by electronic means.the purpose is to further promote the standardization of clinical research of TCM, improve the quality and speed up the process of clinical research.Methods:(1) build the TCM clinical research data in accordance with CDISC standards I will learn the CDISC standards especially SDTM and CDASH and tease out the principles and methods of adding new domain of CDISC SDTM through literature review and Software. At the same time generalize the extremely characteristics data and its formats of Chinese medicine clinical trials by collecting50Case Report Forms.Finally, set one or more the CDISC SDTM new domain which contains features of TCM clinical data according to the principles and methods of adding new domain of CDISC SDTM.(2) Discuss the standardized design of CRF of Clinical Research of TCMI will look back some problems exist in the present CRF’S design of clinical research through literature review.And design the CRF in standardization including its principle, proces,structure and content by the CDISC-CDASH.Results:①Systematicly analysis the content and structure of CRF the clinical trials of traditional Chinese medicine and the establishvariables libraries and analysis of its structural features of clinical research case report form.②Tease out the CDISC-SDTM principles and methods of createing a new field of observational data.③stablished a new domain combined with Chinese characteristics and CDISC.④With CDISC-CDASH requirements on case report forms and combining the characteristics of Chinese medicine clinical research clinics and content of the proposed design principles from the design process, the content and structure of the case report form four aspects of standardized design paper and electronic clinical medicine study case report form.