Clinical Research and Regulatory Support Core

临床研究和监管支持核心

• 批准号: 10685401
• 负责人: Cecilia M. Shikuma
• 金额: $ 32.62万
• 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/10685401
• 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 Skills; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Communities; Community Developments; Community Outreach; Complement; Data; Data Analyses; Databases; Development; Elderly; Ensure; Epidemiology; 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; Medical; Medical Device; Medical center; Mentors; Native Hawaiian or Other Pacific Islander; Nursing Research; Outpatients; Participant; Patient Rights; Perinatal; Persons; Pharmacologic Substance; Physicians; Pilot Projects; Play; Procedures; Process; Professional Organizations; 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; clinical research site; community engagement; community organizations; community setting; design; 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）核心将在增强增强方面起着至关重要的作用 为太平洋创新中心开发强大的临床和转化基础设施（CTR）基础设施， 知识和机会（Piko）。 CRRS核心将提供初级调查员（JI），并建立 调查人员（EI）过渡到CTR跨CTR连续体，具有必要的临床研究专业知识， 进行CTR的资源和设施，以改善土著太平洋人民的健康（IPP）， 定义为夏威夷原住民，其他太平洋岛民和菲律宾人，以及其他医学服务不足的人 脆弱的群体。 CRRS核心还将协助JI/EI导航艰巨的过程，以确保他们的 拟议的研究是道德的，解决了所有人类主题和监管问题。 CRRS核心将 促进整个社区和合作伙伴机构的机构审查委员会程序的协调， 参加专业发展（PD）核心组织的心理活动，与 发展案例报告和输入的生物统计学，流行病学和研究设计（BERD）核心 数据数据库中的数据，并与社区参与和外展（CEO）核心共享 医疗保健专业人员和社区领导者的信息。该核心的具体目的是： 特定目的1：指导CTR研究人员对进行高质量CTR的实际方面 通过协助JI/EI解决研究可行性和实施问题；促进与医疗资源的联系 倡导跨学科和团队科学机会；为CTR提供监管心理支持 执行;参加PIKO赞助的专业发展活动。 特定目的2：通过直接访问关键CTR实施资源和设施 提供CTR人事资源（研究护士/助理和加工实验室技术人员服务）； 提供进入诊所设施的机会；允许访问独立的数据安全监控委员会和道德规范 董事会资源；推进CTR技术并推广以支持T2 -T5临床研究。 CRRS核心将在三个临床站点提供服务-John A. Burns医学院（JABSOM）， 皇后医学中心（QMC）和妇女和儿童医学中心（KMCWC）。作为CRR 医学博士Cecilia M. Shikuma的核心主任，由副校长托德·塞多（Todd Seto）和布利斯（Bliss）支持 医学博士Kaneshiro将分别监督JABSOM，QMC和KMCWC的核心操作。 Venkataraman 医学博士Balaraman将监督道德和监管服务。结合监管和 具有单一核心内CTR实施服务的道德资源将使CRRS核心能够提供 综合和个性化的服务，用于参与CTR的JI/EI。