Core-004

在更大的学习中调整临床和转化研究（CTR）方法和CTSA联盟 卫生系统可以推动研究和改善卫生保健信息的使用，以促进知识和 改进实践。要做到这一点，CTR必须依靠一系列复杂的方法，从新的研究设计， 高维数据分析、因果推理、中介分析和贝叶斯推理方法。 因为方法研究是CTR的一个关键方面，所以吸引最好的统计学家和 流行病学家的CTR，并培养他们的专业发展。了解法规和 驾驭道德和合规环境的能力对CTR也至关重要。过去几年 从NIH数据共享授权到21世纪世纪， 治愈法，病人的“审判权”立法和2018年修订的共同规则法规。我们 拟议的研究方法包括生物统计学，流行病学和 研究设计（BERD）和伦理，监管知识和支持（ERKS）核心。这些基本 核心领导至关重要的活动，以支持临床和转化中心的目标 科学和培训（CCTST）。BERD和ERKS在CCTST中高度集成，其目标 与整体CCTST一致。为了吸引利益相关者，BERD核心将提供专家 与有价值的项目进行磋商和重点合作，并积极促进和领导BERD CTSA联盟的成员。ERKS核心将建立一个道德中心，包括所有 利益攸关方，并加强知情同意程序。促进劳动力发展， 多样性，BERD核心将培养CTR方法学家社区，培养BERD教师， 员工发展，教育和培训临床和转化研究人员在研究设计，数据 管理和数据分析。ERKS核心将提供培训和教育，促进道德和 专业发展中的监管知识。为了组织、集成和优化数据使用， BERD核心将提供支持研究设计，数据管理和数据分析的专业知识， 促进新方法和新程序的开发和推广。ERKS核心将设计和 实施研究启动程序，以促进单一机构审查委员会（IRB）审查， 适应修订后的共同规则中的其他变化。

Aligning Clinical and Translational Research (CTR) methods and the CTSA consortium within a larger Learning Health System can drive research and improve use of health care information to advance knowledge and improve practice. To do this, CTR must rely on a complex array of methods, ranging from new study designs to high-dimensional data analysis, causal inference, mediation analysis, and Bayesian inference methods. Because methodologic research is a key aspect of CTR, it is important to attract the best statisticians and epidemiologists to CTR, and to nurture their professional development. Knowledge of the regulations and the ability to navigate the ethical and compliance landscapes are also essential to CTR. The past few years have seen significant changes in the regulatory framework, from NIH data sharing mandates, to the 21st Century Cures Act, to patient “right to try” legislation and the 2018 revisions to the Common Rule regulations. Our proposed Research Methods encompass the aims and approaches of the Biostatistics, Epidemiology and Research Design (BERD) and Ethics, Regulatory Knowledge, and Support (ERKS) Cores. These essential cores lead critically important activities in support of the aims of the Center for Clinical and Translational Science and Training (CCTST). BERD and ERKS are highly integrated across the CCTST, and their goals align with those of the overall CCTST. To engage stakeholders, the BERD Core will provide expert consultation and focused collaboration with meritorious projects, and actively contribute to, and lead, the BERD community in the CTSA Consortium. The ERKS Core will build an Ethics Center that encompasses all stakeholders and enhances the informed consent process. To promote workforce development and diversity, the BERD Core will cultivate the community of CTR methodologists, fostering BERD faculty and staff development, and educate and train clinical and translational researchers in study design, data management, and data analysis. The ERKS Core will provide training and education and promote ethics and regulatory knowledge in professional development. To organize, integrate, and optimize data use, the BERD Core will provide expertise that supports research design, data management, and data analysis and promote the development and dissemination of new methods and processes. The ERKS Core will design and implement study startup procedures that facilitate single Institutional Review Board (IRB) review and accommodate other changes in the revised Common Rule.