从临床研究数据管理角度设计病例报告表.pdf

Ch inese Journal ofNew D rugs 2007, Vol. 16 N o. 5 2007 16 5 * 1, 2 2 2 2 2 , , , , ( 1南京中医药大学, 南京 210029; 2南京中医药大学附属医院临床药理科, 南京 210029) [ ] 病例报告表( CRF) 是临床研究数据获取的主要工具, 重要性仅次于方案书面与电子 CRF 对于 数据收集与数据管理的效率与数据质量有不同的影响CRF 设计属于临床研究数据管理( CDM ) 设计与计划阶段 的一个程序步骤因此, 从 CDM 的角度出发, 考虑 CRF 的设计要求设计时点流程与设计要点, 不仅有助于获得 正确有效的数据, 还能使数据管理的 他程序步骤的效率提高错误发生率降低 [ ] 临床研究数据管理; 病例报告表; 临床研究 [ ] R95; R96914 [] A [ ] 1003- 3734( 2007) 05- 0339- 05 CRF development from the standpoint of clinical data management 1, 2 2 2 2 2 BU Q ing- an , X IONG N ing-ning , ZOU Jian-dong , JIANG M eng , LIU Fang ( 1N anj ing Un iversity of Trad itional Ch ineseM ed icine, N anj ing 210029, Ch ina; 2D ep artment of C lin ical Pharmacology, TheH osp ital of N anj ing Un ivers ity of Trad itional Ch ineseM ed icine, N anj ing 210029, Ch ina ) [Abstract] Case report form ( CRF) has been used as an essential tool to capture data in the clin- ical studies, wh ich is next to a parw ith the clinical protocol developm ent. U tilization of paper and/or e- lectron ic CRF affects the efficienc of data collection and m anagement asw ell as data qualit . CRF deve-l opment is a part of mi portant processes in preparations and p lans of ClinicalD ataM anagement ( CDM ). From the standpoint of CDM, strategies of CRF development, such as requirem ents, tmi eline, flow chart and ke notes of the CRF design, are defin itel a guarantee for the procurab ilit of accurate and valid da- ta, but also facilitate efficienc and qualit of other CDM-related processes. [Keywords] clinical datamanagement( CDM); case report form ( CRF); clinical research ( CDM )