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.

目前存在关于如何进行临床试验的关键障碍，包括不一致（或 培训，以及被动学习技术用于发展临床研究的劳动力。 我们的小组领导努力确定与临床研究相关的临床研究能力领域;然而， 课程映射到这些领域和客观的能力为基础的评估，这些领域的具体 能力不存在。因此，迫切需要开发、演示和 为参与执行临床试验的临床研究人员提供能力培训 在CTSA联盟中。为此，我们将努力协调多个核心临床 研究能力纳入一套单一的，基于角色的标准（在第二阶段的提高 临床研究专业人员培训和资格[ECRPTQ]项目由NCATS支持）， 作为开发基于能力的课程、展示其使用和传播的框架， 在CTSA中心进行培训我们的提案题为“发展、执行和评估 新的培训领域为基础的竞争力（钻石），其目标是开发一个在线 教育门户（DIAMOND门户），提供基于能力的教育服务和评估， 证明该课程整合到DIAMOND中心的CTSA临床试验教育计划中， 以促进更有效、高效和安全地执行临床试验的方式与合作伙伴研究中心合作; 传播给更广泛的受众。我们的理由是，使用基于能力的教育产品， 经验证的观察评估规则将确保临床研究人员如何 培训标准，优化临床试验执行的质量和效率。该项目解决了 作为从干预性临床试验中得出科学“答案”，临床试验研究中的重要问题是 仅与执行研究的质量一样好，并依赖于高度胜任的研究 团队执行研究程序。因此，将新型药物、器械和干预措施转化为 改善人类健康需要一个准备充分，有能力的临床研究专业人员队伍， 切实有效地进行审判。地图的创新发展与示范 然后，通过DIAMOND门户网站，将基于能力的评估免费分发给所有CTSA 中心和超越，我们假设，最终将改善临床试验的执行，可能导致 加速健康成果。最终，钻石将促进提高知识和能力， CTSA联盟内的临床研究人员，并通过以下方式加强临床试验研究质量 实现NCATS的愿景，在CTSA中心和整体之间建立高效和有效的临床试验网络 财团