《CDISC编码标准和21CFR Part11在医学研究系统中的应用》.pptVIP

周 洪 Zhou Hong zhouhong@dapchina.cn 数据采集和处理系统提供商 Data acquisition and processing system provider ;标准让数据互相认识Standardized data can communicate seamlessly;临床研究数据是否需要标准化？Does Clinical data need standardization ?;新药研发到上市的路线图Pathway from Compound to New Drug;药物上市后的研究Post-marketing clinical reserach;新药研究和上市后研究的区别pre post marketing research;Every step generates data Every step needs data management;临床数据采集的目的Objective of clinical research data;临床数据的应用流程Operational Process for Clinical Data;EDC 和临床数据的现状Current Status for EDC and Clinical Data;EDC 和临床数据的现状Current Status for EDC and Clinical Data;样本数据示例Sample;暴露出的问题The Problems;如何自动统计女性数量How do you automate counting women?;临床数据标准化非常关键和重要！ Clinical data Standardization is very important and critical! ;数据的可交换性Data Exchangeability ;CDISC是什么?;SDTM的基本模型SDTM’s fundamental model for operational data;Interventions 干预;CDISC SDTM 域注解 Domains comments;FDA对数据标准化的态度FDA’s Stands on Clinical Data Standardization;FDA申报标准数据包Submission Data Package;申报数据进入FDA的流程 Flow for Submission Data within FDA;常用创建SDTM和ADaM流程Commonly Used Procedure for Creating SDTM and ADaM;转换为SDTM和ADaM存在的问题Issues in Mapping SDTM and ADaM from Raw;理想的步骤The Should-be Procedure;部分的解决方案Partial Solutions;CDISC 总结Summary;如何保证电子数据的有效和安全?Ensures security and data administration are effectively managed;21CFR Part11 是什么?;21CFR Part11的重点Keyponits;我们DAP在做什么?What we are doing in this field？;DAP的医学研究系统Clinical research system developed by DAP;DAP的外部专家External Mentors;DAP的客户 Customs;DAP的精神 Spirit;dsfdbsy384y982ythb3oibt4oy39y409705923y09y53b2lkboi2y58wy0ehtoibwoify98wy049ywh4b3oiut89u983yf9ivh98y98sv98hv98ys9f698y9v698yv98x98tb98fyd98gyd98h98ds98nt98d8genklgb4klebtlkb5k tkeirh893y89ey698vhkrne lkhgi8eyokbnkdhf98hodf hxvy78fd678t9fdu90gys98y9shihixyv78dfhvifndovhf9f8yv9onvkobkw kjfegiudsfdbsy384y982ythb3oibt4oy39y409705923y09y53b2lkboi2y58wy0ehtoibwoify98wy049ywh4b3oiut89u983yf9ivh98y98sv98hv98ys9f698y9v698yv98x98tb98fyd98gyd98h98ds98nt98d8g