CAJ | 학술논문

临床试验结果的科学性依赖于临床研究过程中收集的正确数据，而病例报告表（CRF）正是收集数据的工具和载体。CRF设计的质量会对数据库建设、数据录入及数据清理工作带来影响，因此从数据管理整体来认识CRF设计，更有利于收集到正确可靠的数据。本文以临床试验数据管理过程中的一些实例，对CRF的内容设计、结构设计以及相关注意事项进行讨论，为数据管理工作和临床研究提供借鉴。
림상시험결과적과학성의뢰우림상연구과정중수집적정학수거，이병례보고표（CRF）정시수집수거적공구화재체。CRF설계적질량회대수거고건설、수거록입급수거청리공작대래영향，인차종수거관리정체래인식CRF설계，경유리우수집도정학가고적수거。본문이림상시험수거관리과정중적일사실례，대CRF적내용설계、결구설계이급상관주의사항진행토론，위수거관리공작화림상연구제공차감。
Scientific clinical trial results depend on collecting correct data in the research. Case report form (CRF) is the data collection tool and carrier. The design of CRF directly impacts on all aspects of the database construc-tion, data entry and cleaning, therefore the data management from the perspective on CRF design is more conduc-tive to collect accurate and reliable data. In this paper, the data management processes some examples for the de-sign of CRF content and construction, and related considerations in order to provide references to data management and clinical investigation.