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， CRRS 核心将提供知识和机会 (PIKO)，并建立初级研究者 (JI)。 研究者 (EI) 在 CTR 连续体中过渡到 CTR，并具有必要的临床研究专业知识， 进行旨在改善太平洋原住民 (IPP) 健康的 CTR 的资源和设施， 定义为夏威夷原住民、其他太平洋岛民、菲律宾人以及其他医疗服务不足和 CRRS 核心还将协助 JI/EI 完成确保他们得到保护的艰巨过程。 拟议的研究符合伦理，并解决所有人类受试者和监管问题。 促进整个社区和伙伴机构机构审查委员会程序的统一， 参加专业发展（PD）核心组织的指导活动，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 数据存入研究数据库，并与社区参与和外展 (CEO) 核心合作共享 该核心的具体目标是： 具体目标 1：指导 CTR 调查人员进行高质量 CTR 的实际方面 协助 JI/EI 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 提供监管指导支持； 实施；参与 PIKO 赞助的专业发展活动。 具体目标 2：通过以下方式实现对关键 CTR 实施资源和设施的直接访问： 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）； 提供使用诊所设施的机会；允许使用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 技术和推广以支持 T2-T5 临床研究。 CRRS 核心将在三个临床地点提供服务：约翰·A·伯恩斯医学院 (JABSOM)、 皇后医疗中心 (QMC) 和卡皮奥拉尼妇女儿童医疗中心 (KMCWC) 作为 CRRS。 核心董事 Cecilia M. Shikuma 医学博士，由副核心董事 Todd Seto 医学博士和 Bliss 提供支持 Kaneshiro 医学博士将分别负责 JABSOM、QMC 和 KMCWC 的核心运营。 医学博士巴拉拉曼 (Balaraman) 将负责监管道德和监管服务的创新。 道德资源与单一核心内的 CTR 服务实施将使 CRRS 核心能够提供 为JI/EI从事CTR提供一体化、个性化服务。