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

项目摘要 标准医疗电子健康记录（EHR）治疗计划在实施前构建一次 通过标准化支持质量。相比之下，临床试验的治疗计划可能支持 必须为每项新试验和每个新增试验点从头开始构建， 有治疗计划，往往需要配置新的药物，许多辅助程序， 和研究资金需求。目前的模式是昂贵的，复杂的，效率低下的。代表 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。的 该项目的目标是在多个国家癌症研究所支持的癌症中心开发流程， 开发单一版本的EHR临床试验治疗计划，可在多个机构部署， 支持NCI赞助的网络研究。各位议员会研究一个问题： 临床试验站点开发方法来标准化工作流程、药物处方集、药物管理程序 和实验室的要求，导致创建的组件，为一个标准化的，电子的，临床- 试建系统？具体目标如下：1）确定EHR当前执行的任务 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， 联合体的各个成员站点; 2）在可能的情况下，标准化每个任务中的流程 并记录需要在各地点进行修改的差异; 3）制定 EHR治疗计划模块，可重复使用以执行相同研究协议任务的组成部分 在多个地点进行，同时遵守联营体成员组织的要求; 4)为将与NCI和EHR提供商合作的联盟组织领导结构， 监督这一倡议，以确保朝着建立一个全面的 自动化电子临床试验构建系统，将促进所有NCI的临床试验激活， 支持的网络; 5）建立标准化的电子临床试验构建模块，可以进行未来的试点 在每个机构对指定的一组NCI申办的临床试验进行测试;以及6）促进开发 新的EHR流程的指标，可以证明是否更一致的病人护理，减少 药物错误，以及较少的不良事件，这是由于临床试验构建模块的标准化方法。

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.