Clinical and Data Management Core

在任何临床研究项目中，标准化的患者护理和患者数据是最基本的， 宝贵的资源。临床和数据管理核心（CDMC）旨在支持和 在日益依赖电子数据的临床环境中响应临床研究。 具体而言，CDMC将创建基于电子健康记录（EHR）的镰状细胞登记系统（SCR）， 允许在与患者接触的点处进行真实的和有效的数据输入。CDMC认识到， 将协调纯粹出于临床目的而输入的EHR数据的不同且经常相互冲突的要求 输入数据用于研究。基于EHR的SCR将允许数据输入一次， 临床和研究需要。CDMC将为临床护理和临床治疗制定最佳实践标准。 使用基于EHR的工具进行实施和监测。最好的创造和执行 实践标准将减少众所周知的和可避免的影响患者结局的护理障碍 镰状细胞病最佳实践的标准化将是高效临床 研究计划。CDCM的专业知识，EHR将成为质量驱动的临床 镰状细胞病的研究计划。最后，CDMC将致力于制定临床研究计划 有足够的患者数量，并有详细的临床数据和生物样本注释， 参与多中心合作小组和行业赞助的镰状细胞病临床研究。 CDMC的工具和专业知识在此应用于镰状细胞病。然而，基于EHR的 CDMC所创造的工具和专业知识可以应用于任何疾病。CDMC合并可用 生物信息学的健康信息专业知识，以创建一个完全可持续和广泛适用的核心 resource.确保EHR数据准确性、完整性和质量的系统是任何 临床研究计划。该技术的应用将保证CDMC的可持续性 以及其他儿童慢性病和孤儿病的专业知识。

In any clinical research program, standardized patient care and patient data are the most fundamental and valuable resources. The Clinical and Data Management Core (CDMC) is designed to be supportive of and responsive to clinical research in a clinical environment that is increasingly dependent on electronic data. Specifically, the CDMC will create an Electronic Health Record (EHR)-based Sickle Cell Registry (SCR) to permit real time and efficient data entry at the point of contact with the patient. The CDMC recognizes and will reconcile the differing and often conflicting requirements of EHR data entered for purely clinical purposes with data entered for research. The EHR-based SCR will permit data to be entered once and jointly serve clinicaland research needs. The CDMC will create best practice standards for clinical care and clinical research using EHR-based tools for implementation and monitoring. The creation and enforcement of best practice standards will reduce well-known and avoidable barriers to care affecting the outcomes of patients with sickle cell disease. Standardization of best practices will be the cornerstone of a productive clinical research program. The expertise in the CDCM, the EHR will be an integral part of a quality-driven clinical research program in sickle cell disease. Lastly, the CDMC will aim to develop a clinical research program that has sufficient patient numbers with detailed annotation of clinical data and biospecimens to permit future involvement in multi-center cooperative group and industry-sponsored clinical research in sickle cell disease. The tools and expertise of the CDMC is applied herein to sickle cell disease. However, the EHR-based tools created and the expertise of the CDMC can be applied to any disease. The CDMC merges available expertise in Health Informations with Bioinformatics to create a fully sustainable and broadly applicable core resource. Systems to ensure EHR data accuracy, completeness and quality are a limiting factor in any clinical research program. Sustainablility of the CDMC will be assured by the application of this technology and expertise to other chronic and orphan diseases of childhood.