Clinical Data Acquisition Standards Harmonization importance and benefits in clinical data management.
Clinical Data Acquisition Standards Harmonization importance and benefits in clinical data management.
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DOI：
10.4103/2229-3485.167101
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发表时间：
2015-10-01
影响因子：
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通讯作者：
Gaddale, Jagadeeswara Rao
中科院分区：
文献类型：
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作者：
Gaddale, Jagadeeswara Rao
在临床试验过程中，精确、简明的源头数据收集是必不可少的，需要进行统计分析以得出主要和次要终点。原始数据收集的质量直接影响到根据统计分析计划产生的统计输出。因此，用于数据转录的数据收集工具必须清晰、易懂、准确，这有助于研究者提供准确的受试者数据。临床数据采集标准协调（CDASH）为跨治疗领域的大多数临床试验通常使用的领域制定病例报告表格（CRF）提供指导。本白皮书描述了CDASH标准的重要性，它的优点及其对设计CRF的努力和成本的影响。
In the clinical trial process, precise and concise data collection at the source is imperative and requires statistical analysis to be performed to derive the primary and secondary endpoints. The quality of raw data collection has a direct impact on the statistical outputs generated as per the statistical analysis plan. Hence, the data collection tools used for data transcription must be clear, understandable, and precise, which helps the investigator to provide the accurate subject data. Clinical Data Acquisition Standards Harmonization (CDASH) provides guidance to develop the case report form (CRF) for domains that are commonly used for the majority of the clinical trials across the therapeutic areas. This white paper describes the importance of CDASH standards, its advantages and its impact on the efforts and the cost in designing the CRF.