Division of Urologic Surgery, Duke University Medical Center, Durham, North Carolina 27710, USA.
J Endourol. 2011 Nov;25(11):1811-3. doi: 10.1089/end.2011.0402. Epub 2011 Oct 19.
The Clinical Research Office of the Endourological Society (CROES) conducts large-scale, international, multicenter clinical trials in the field of endourology. One of the major challenges that these trials pose is to ensure that data collected remotely and online within a very short time frame are valid and reliable. This editorial describes a formal process for auditing the data by the CROES Audit Committee. The audit process presented is largely based on an automatic scoring system, which takes into consideration several parameters to determine the quality of the data and of the participating institution. This process is dynamic in nature and offers live monitoring of both patient data and study centers.
欧洲泌尿外科学会临床研究办公室(CROES)在泌尿外科学领域开展大规模、国际性、多中心临床试验。这些试验面临的主要挑战之一是确保在极短时间内远程和在线收集的数据是有效和可靠的。本社论描述了由 CROES 审计委员会对数据进行审核的正式流程。所提出的审核流程主要基于自动评分系统,该系统考虑了多个参数来确定数据和参与机构的质量。该流程具有动态性质,可实时监测患者数据和研究中心。