Clinical Research and Regulatory Support Core

临床研究和监管支持核心

• 批准号: 10474450
• 负责人: Cecilia M. Shikuma
• 金额: $ 32.55万
• 依托单位: UNIVERSITY OF HAWAII AT MANOA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10474450
• 关键词: Address; Advocate; Age; Attention; Behavior Therapy; Biometry; Burn injury; COVID-19 pandemic; Case Report Form; Child; Chronic Disease; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Communities; Community Developments; Community Outreach; Complement; Data; Data Analyses; Databases; Development; Elderly; Ensure; Ethics; Faculty; Failure; Feasibility Studies; Filipino; Food Supplements; Funding; Goals; Hawaii; Health; Health Professional; Human Resources; Indigenous; Infrastructure; Inpatients; Institution; Institutional Review Boards; Knowledge; Laboratory Technicians; Lead; Medical; Medical Device; Medical center; Mentors; Native Hawaiian; Nursing Research; Outpatients; Pacific Islander; Participant; Patient Rights; Perinatal; Persons; Pharmacologic Substance; Physicians; Pilot Projects; Play; Procedures; Process; Reduce health disparities; Regulatory Affairs; Research; Research Design; Research Personnel; Resources; Role; Safety; Science; Scientist; Services; Technology; Time; Translational Research; Trust; Underserved Population; Universities; Vulnerable Populations; Woman; Work; base; clinical research site; community engagement; community setting; design; epidemiology study; health disparity; human subject; improved; innovation; medical schools; medically underserved population; operation; outreach; patient safety; programs; psychologic; sound; translational scientist; wasting

The proposed Clinical Research and Regulatory Support (CRRS) Core will play a vital role in enhancing the development of a robust clinical and translational (CTR) infrastructure for the Center for Pacific Innovations, Knowledge, and Opportunities (PIKO). The CRRS Core will provide Junior Investigators (JI), and Established Investigators (EI) transitioning to CTR across the CTR continuum, with the necessary clinical research expertise, resources, and facilities to conduct CTR aimed at improving the health of Indigenous Pacific People (IPP), defined as Native Hawaiians, Other Pacific Islanders, and Filipinos, and other medically underserved and vulnerable groups. The CRRS Core will also assist JI/EI in navigating the daunting process of ensuring that their proposed research is ethical and addresses all human subject and regulatory concerns. The CRRS Core will promote harmonization of institutional review board procedures throughout community and partner institutions, participate in mentoring activities organized by the Professional Development (PD) Core, collaborate with the Biostatistics, Epidemiology, and Research Design (BERD) Core in developing case report forms and inputting data into the study database, and work with the Community Engagement and Outreach (CEO) Core to share information with health care professionals and community leaders. This Core’s Specific Aims are: Specific Aim 1: Mentor CTR investigators on the practical aspects of conducting high-quality CTR by assisting JI/EI with study feasibility and implementation issues; facilitating linkage to medical resources and advocate for transdisciplinary and team-science opportunities; providing regulatory mentoring support for CTR implementation; participating in PIKO-sponsored professional development activities. Specific Aim 2: Enable direct access to critical CTR implementation resources and facilities by providing CTR personnel resources (research nurse/associate and processing laboratory technician services); providing access to clinic facilities; enabling access to an independent Data Safety Monitoring Board and Ethics Board resources; advancing CTR technology and outreach to support T2–T5 clinical research. The CRRS Core will provide services at three clinical sites – John A. Burns School of Medicine (JABSOM), Queen’s Medical Center (QMC), and Kapiolani Medical Center for Women and Children (KMCWC). As CRRS Core Director, Cecilia M. Shikuma, MD, supported by Associate Core Directors Todd Seto, MD, and Bliss Kaneshiro, MD, will oversee the Core operations at JABSOM, QMC and KMCWC, respectively. Venkataraman Balaraman, MD, will oversee the ethics and regulatory services. The innovation of combining regulatory and ethics resources with CTR implementation services within a single core will allow the CRRS Core to offer integrated and personalized services to JI/EI engaging in CTR.

拟议的临床研究和监管支持（CRRS）核心将在加强 为太平洋创新中心开发强大的临床和转化（CTR）基础设施， 知识和机会（PIKO）。CRRS核心将提供初级研究者（JI）， 研究者（EI）在CTR连续体中过渡到CTR，具有必要的临床研究专业知识， 资源和设施，以开展旨在改善太平洋土著人民健康的社区康复， 定义为夏威夷土著人，其他太平洋岛民和菲律宾人，以及其他医疗服务不足的人， 弱势群体CRRS核心还将协助联合执行/环境影响评估在确保其 拟议的研究符合伦理，并涉及所有人类受试者和监管问题。CRRS核心将 促进整个社区和伙伴机构的机构审查委员会程序的统一， 参加由专业发展（PD）核心组织的辅导活动，与 生物统计学，流行病学和研究设计（BERD）开发病例报告表和输入的核心 数据输入研究数据库，并与社区参与和外联（CEO）核心合作， 与卫生保健专业人员和社区领导人的信息。该核心的具体目标是： 具体目标1：指导CTR研究者进行高质量CTR的实践方面 协助联合执行/环境倡议处理研究可行性和执行问题;促进与医疗资源的联系， 倡导跨学科和团队科学机会;为CTR提供监管指导支持 执行;参加PIKO主办的专业发展活动。 具体目标2：通过以下方式直接获取关键CTR实施资源和设施： 提供CTR人力资源（研究护士/助理和处理实验室技术人员服务）; 提供诊所设施的使用权;允许使用独立的数据安全监测委员会和伦理委员会 董事会资源;推进CTR技术和推广，以支持T2-T5临床研究。 CRRS核心将在三个临床站点提供服务- John A.伯恩斯医学院（JABSOM）， 皇后医疗中心（QMC）和Kapiolani妇女和儿童医疗中心（KMCWC）。作为CRRS 核心总监，Cecilia M. Shikuma，医学博士，由副核心董事托德濑户，医学博士和布利斯提供支持 Kaneshiro博士将分别监督JABSOM、QMC和KMCWC的核心业务。Venkataraman 医学博士巴拉拉曼将监督道德和监管服务。将监管和 道德资源与CTR实施服务在一个单一的核心将允许CRRS核心提供 为参与CTR的联合执行/环境影响评估提供综合和个性化的服务。