CCR Research Nursing

CCR 研究护理

• 批准号: 10703113
• 负责人: Cheryl Royce
• 金额: $ 2828.82万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10703113
• 关键词: AIDS related cancer; Adherence; Adverse event; Area; Basic Science; Behavior; Budgets; CCR; Cancer Burden; Clinic; Clinical; Clinical Investigator; Clinical Nursing Research; Clinical Research; Clinical Treatment; Clinical Trials; Code; Collaborations; Collection; Competence; Complex; Continuing Education; Country; Critical Thinking; Data; Data Management Resources; Development; Discipline of Nursing; Documentation; Education; Ensure; Equilibrium; Ethics; HIV/AIDS; Individual; Information Technology; Informed Consent; Knowledge; Maintenance; Maryland; Measurement; Medical; Mentorship; Mission; Monitor; Nurse' s Role; Nurses; Nursing Models; Nursing Research; Nursing Societies; Nursing Specialties; Oncology; Oncology Nurse; Patient Care; Patient Recruitments; Patients; Performance; Persons; Phase; Physicians; Play; Prevention strategy; Protocol Compliance; Protocols documentation; Records; Reporting; Research; Role; Safety; Secure; Serious Adverse Event; Specialist; System; Time; Training; Translating; Translational Research; Translations; base; cancer type; clinical trial implementation; cohesion; data management; electronic data; human subject; innovation; novel therapeutics; programs; quality assurance; recruit; skills

The oncology research nurse coordinator is a subspecialty nursing role that safeguards the clinical trial's integrity while balancing the coordination of clinical trials with the management of patients on those trials. As a licensed professional nurse, the oncology RNC brings a background of scientific knowledge, critical-thinking skills, and the understanding of individual and group behavior. The RNC supports a wide range of activities to support clinical research and patient care while assisting clinical investigators throughout every phase of clinical trial development and implementation. The RNC role includes patient recruitment and retention, informed consent, management and education of clinical trial patients, documentation and document management, data management and information technology, adherence to ethical standards, protocol compliance, maintenance of detailed regulatory records, collaboration with Licensed Medical Practitioners, reporting of adverse events, and determination of protocol feasibility as it pertains to implementation issues. Regulatory requirements for protocols have become significantly more complex. The RNC facilitates the accurate and timely submission of various regulatory documents such as annual FDA reports, continuing reviews (CR), IND safety reports, and maintenance of regulatory binders. The RNC manages and monitors a variety of electronic data management systems and oversees how data are entered in the systems, validated or cleaned, transferred and coded, and kept secure. The RNC plays a crucial role in identifying, monitoring and reporting adverse events for patients prior to, during and following treatment on a protocol. The timely submission of unanticipated problems, submission of serious adverse events and routine adverse event reporting are all coordinated through the RNC. The RNC ensures the collection of accurate data and participates in regular quality assurance data monitoring and audits. As a licensed professional nurse with extensive training in oncology and research, the RNC plays a vital role in clinical research and is integral to research conduct at every level, from providing patient care, to coordinating studies, to safeguarding the clinical trial's integrity. The Office of Research Nursing strongly values the research nurse coordinator as a subspecialty of nursing and has based training and performance measurements on the Oncology Nursing Society's Clinical Trials Nurse model, framework and competencies.): Reviewed by the OAR and determined to be aligned in FY19. High priority HIV/AIDS studies constitute approximately 10% of this core's budget. CCR physicians treat thousands of people from around the country every year with novel therapies through a clinical trials program at the Clinical Research Center (CRC) in Bethesda, Maryland. The role of the clinical research nurse coordinator (RNC) is a specialty nursing role in oncology (including AIDS related malignancies) and HIV/AIDS and critical to the effective and safe implementation of clinical trials. The RNC is highly trained with expertise in the conduct of research on human subjects in areas such as protocol feasibility and compliance, adherence to ethical standards, regulatory requirements, data management, in addition to traditional nursing competencies. The objectives of the Office are to recruit, train and retain a unique, cohesive team of superior research nurse specialists who carry out the mission of the CCR through a culture that supports continuing education, mentorship, professional development, and collaboration while balancing comprehensive patient coordination and quality clinical and translational research.

肿瘤研究护士协调员是一个亚专科护理角色， 临床试验的完整性，同时平衡临床试验与 这些试验中的患者管理。作为一名有执照的专业护士，肿瘤学RNC 带来了科学知识的背景，批判性思维能力，以及对 个人和群体行为的影响RNC支持广泛的活动， 临床研究和患者护理，同时协助临床研究者在整个 临床试验开发和实施阶段。RNC角色包括患者 临床试验的招募和保留、知情同意、管理和教育 患者、文档和文件管理、数据管理和信息技术， 遵守伦理标准、方案合规性、维护详细的法规 记录、与执业医师合作、不良事件报告，以及 确定与实施问题有关的方案可行性。监管 对协议的要求已经变得非常复杂。RNC促进了 准确及时地提交各种监管文件，如FDA年度报告， 持续审查（CR）、IND安全性报告和监管文件夹的维护。共和党全国委员会 管理和监控各种电子数据管理系统，并监督数据如何 进入系统，验证或清洗，转移和编码，并保持安全。共和党全国委员会 在识别、监测和报告患者不良事件方面起着至关重要的作用 在方案治疗之前、期间和之后。及时提交未预料到的 问题、严重不良事件的提交和常规不良事件报告都是 通过RNC协调。RNC确保收集准确的数据，并参与 定期质量保证数据监测和审计。作为一名有执照的专业护士， RNC在肿瘤学和研究方面接受了广泛的培训，在临床研究中发挥着至关重要的作用 并且是从提供病人护理到 协调研究，以维护临床试验的完整性。研究办公室 护理学非常重视研究护士协调员作为护理学的一个亚专业， 基于肿瘤护理学会临床试验的培训和绩效评估 护士模式、框架和能力。）：经OAR审查并确定与 FY19.高度优先的艾滋病毒/艾滋病研究约占该核心预算的10%。CCR 医生们每年用新疗法治疗来自全国各地的数千人 通过位于马里兰州贝塞斯达的临床研究中心（CRC）的临床试验项目。 临床研究护士协调员（RNC）的角色是一个专业护理角色， 肿瘤（包括艾滋病相关的恶性肿瘤）和艾滋病毒/艾滋病， 安全开展临床试验。共和党全国委员会训练有素， 在方案可行性和合规性等领域对人类受试者进行研究， 遵守道德标准、法规要求、数据管理，以及 传统护理能力。该办公室的目标是征聘、培训和 保留一个独特的，有凝聚力的上级研究护士专家团队，他们执行 CCR的使命，通过支持继续教育，指导， 专业发展和协作，同时平衡全面的患者协调 以及高质量的临床和转化研究。