CCSG supplement: Creating an efficient clinical trial build system via the Clinical Trials Rapid Activation Consortium (CTRAC)

项目总结 医疗标准电子健康记录(EHR)治疗计划在实施之前构建一次 并通过标准化来支持质量。相比之下，临床试验的治疗计划构建可能会支持 对于每个新的试验和每个增加的站点，必须从头开始建立少到零个试验参与者，以及 有治疗计划，通常需要配置新的药物，许多辅助程序， 和研究财务要求。目前的模式成本高昂、复杂且效率低下。代表们 五个癌症中心同意成为该项目的临床试验快速激活联盟(CTRAC)的一部分。这个 该项目的目标是开发跨NCI支持的多个癌症中心的流程，以促进 制定单一版本的EHR临床试验治疗计划，可在#年在多个机构部署 支持NCI赞助的网络研究。成员们将调查这个问题：一个小财团能否 临床试验站点开发方法来标准化工作流程、药物处方、给药程序、 和实验室要求导致创建标准化、电子化、临床化的组件- 试验建立系统？具体目标如下：1)确定目前由电子病历执行的任务 研究治疗计划(SOP、政策和工作流程)，并定义这些SOP之间的差异 联合体的个别成员站点；2)尽可能标准化每项任务中的流程 并记录需要跨站点进行修改的差异；3)制定总体评估 EHR治疗计划模块，可重复使用以执行相同研究方案任务的组成部分 在多个地点保持遵守联合体成员组织的要求； 4)组织财团的领导结构，该财团将与NCI和EHR提供商合作，以 监督这一计划，以确保朝着创造一个充分的 自动化电子临床试验构建系统，将促进激活所有NCI- 支持的网络；5)建立标准化的电子临床试验构建模块，可在未来进行试验 在每个机构测试由NCI赞助的一组特定的临床试验；以及6)促进开发 新的电子病历流程的指标，可以证明更一致的患者护理，减少了 临床试验构建模块的标准化方法减少了用药错误，减少了不良事件。

PROJECT SUMMARY Standard-of-care electronic health records (EHR) treatment plans are constructed once prior to implementation and support quality through standardization. By comparison, treatment-plan builds for clinical trials may support as few as zero trial participants, must be built from the ground up for each new trial and at each added site, and have treatment plans that often require configurations for novel medications, numerous ancillary procedures, and research finance requirements. The current paradigm is costly, complex, and inefficient. Representatives of five cancer centers agreed to be part of the project’s Clinical Trials Rapid Activation Consortium (CTRAC). The project’s goal is to develop processes across multiple NCI-supported cancer centers that will facilitate the development of single builds of EHR clinical-trial treatment plans that can be deployed at multiple institutions in support of NCI- sponsored network studies. Members will investigate the question: can a small consortium of clinical trials sites develop methods to standardize workflows, drug formularies, drug administration procedures, and laboratory requirements leading to the creation of the components for a standardized, electronic, clinical- trials build system? Specific aims are as follows: 1) To identify the tasks currently performed by EHR investigational treatment plans (SOPs, policies, and workflows) and to define differences among these SOPs at the individual member sites of the consortium; 2) To standardize the processes within each task where possible and document differences that would require modifications across sites; 3) To develop a master assessment of EHR treatment-plan modules that could be reused to perform components of the same research protocol tasks at multiple sites while maintaining compliance with the requirements of member organizations of the consortium; 4) To organize a leadership structure for the consortium that will work with the NCI and an EHR provider to oversee this initiative to assure that adequate progress is made toward the ultimate goal of creating a fully automated electronic clinical-trial build system that will facilitate the activation of clinical trials across all NCI- supported networks; 5) To build standardized electronic clinical-trial build modules that could undergo future pilot testing at each institution for a specified group of NCI-sponsored clinical trials; and 6) To facilitate development of metrics for the new EHR processes that can demonstrate whether more consistent patient care, reduced medication errors, and fewer adverse events result from a standardized approach to clinical-trial build modules.