Clinical Research and Regulatory Support Core

临床研究和监管支持核心

• 批准号: 10281549
• 负责人: Cecilia M. Shikuma
• 金额: $ 32.28万
• 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/10281549
• 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 Island Americans; Participant; Patient Rights; Perinatal; Pharmacologic Substance; Physicians; Pilot Projects; Play; Procedures; Process; 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）核心将在加强药物治疗方面发挥至关重要的作用