Development, Implementation and AssessMent of Novel Training in Domain-based Competencies (DIAMOND)

新型领域能力培训的开发、实施和评估（DIAMOND）

• 批准号: 9319951
• 负责人: VICKI L ELLINGROD
• 金额: $ 81.62万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-06 至 2020-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9319951
• 关键词: Address; Assessment tool; Clinical; Clinical Competence; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical assessments; Competence; Conduct Clinical Trials; Development; Devices; Education; Educational Curriculum; Educational Models; Effectiveness; Ensure; Future; Goals; Health; Housing; Human; Individual; Intervention; Knowledge; Lead; Learning; Maps; Measures; Michigan; Ohio; Outcome; Patient Self-Report; Phase; Principal Investigator; Procedures; Professional Education; Randomized; Regulation; Research; Research Personnel; Resources; Role; Site; System; Techniques; Time; Training; Translational Research; Translational trial; Translations; Work; base; clinical application; design; improved; innovation; novel; novel therapeutics; programs; skills; tool; trial comparing; vision science

Critical impediments currently exist regarding how clinical trials are conducted which include inconsistent (or absent) training, as well as passive learning techniques used for developing the clinical research workforce. Our group lead efforts to identify clinical research competency domains related to clinical research; however a curriculum mapped to these domains and objective competency based assessments for these domain-specific competencies don’t exist. Therefore there exists a critical need to develop, demonstrate, and publically disseminate competency-based training for clinical research personnel involved in executing clinical trials throughout the CTSA consortium. To do this, we will build upon our efforts to harmonize multiple core clinical research competencies into a set of single, role-based standards (developed in Phase II of the Enhancing Clinical Research Professionals’ Training & Qualification [ECRPTQ] project supported by NCATS) that serve as the framework for developing a competency-based curriculum, demonstrating its use, and disseminating this training across CTSA hubs. Our proposal entitled, Development, Implementation and AssessMent Of Novel Training in Domain-based Competencies (DIAMOND), has the objective to develop an online educational portal (DIAMOND portal) for competency-based educational offerings and assessments and to demonstrate integration of this curriculum into CTSA clinical trial education programs at DIAMOND hubs and partner sites in ways that promote the more effective, efficient, and safe execution of clinical trials; allowing for dissemination to a broader audience. Our rationale is that use of competency-based educational offerings and validated observational assessment rubrics will ensure consistency in how clinical research personnel are trained to standards that optimize the quality and efficiency of clinical trial execution. This project addresses a significant issue in clinical trials research as scientific ‘answers’ derived from interventional clinical trials are only as good as the quality with which the study is executed and are dependent on a highly competent study team to execute the research procedures. Therefore, translation of novel drugs, devices, and interventions into improved human health requires a well-prepared, competent workforce of clinical research professionals who effectively and efficiently conduct trials. The innovative development and demonstration of mapped competency based assessments through the DIAMOND portal will then be freely disseminated to all CTSA hubs and beyond, which we hypothesize, will eventually improve clinical trials execution, potentially resulting in accelerated health outcomes. Ultimately, DIAMOND will facilitate improved knowledge and capacity of the clinical research workforce within the CTSA consortium and strengthen clinical trials research quality by enabling NCATS’ vision for an efficient and effective clinical trials network between the CTSA hubs and overall consortium.

目前存在有关如何进行临床试验的关键障碍，包括不一致（或 培训以及用于发展临床研究人员的被动学习技术。 我们的小组领导努力确定与临床研究有关的临床研究能力领域；但是 映射到这些领域的课程和这些特定领域的基于客观能力的评估 能力不存在。存在着开发，证明和公开的迫切需​​求 为执行临床试验的临床研究人员传播基于能力的培训 通过CTSA财团。为此，我们将基于协调多个核心临床的努力 研究能力符合一组基于角色的标准（在增强的第二阶段开发 临床研究专业人员的培训和资格[ECRPTQ]项目由NCAT支持） 作为开发基于能力的课程的框架，证明其使用并传播 跨CTSA轮毂的培训。我们的提议为题为，发展，实施和评估 基于领域的能力（Diamond）的新颖培训的目的是开发在线 教育门户网站（钻石门户）用于基于能力的教育产品和评估以及 证明该课程将钻石枢纽和 伴侣站点以促进临床试验更有效，有效和安全执行的方式；允许 向更广泛的受众传播。我们的理由是使用基于能力的教育产品和 经过验证的观察评估标题将确保临床研究人员的一致性 培训了优化临床试验执行质量和效率的标准。这个项目解决了 临床试验研究中的重大问题是介入临床试验的科学“答案”是 仅与研究的质量一样好，并取决于一项高度胜任的研究 团队执行研究程序。因此，将新型药物，设备和干预措施的翻译转换为 改善的人类健康需要临床研究专业人员准备充分的，有能力的劳动力 有效有效地进行试验。映射的创新发展和演示 然后，通过钻石门户的基于能力的评估将自由传播到所有CTSA 我们假设的枢纽及其他地区最终将改善临床试验的执行，可能导致 加速健康结果。最终，钻石将促进提高的知识和能力 CTSA财团内的临床研究劳动力和强有力的临床试验研究质量 使NCAT的愿景能够在CTSA中心之间建立有效有效的临床试验网络 财团。