CCR Research Nursing

CCR 研究护理

• 批准号: 10926689
• 负责人: Cheryl Royce
• 金额: $ 3190.15万
• 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/10926689
• 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; Ethics; HIV/AIDS; Individual; Information Technology; Informed Consent; Knowledge; Licensing; 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; Training; Translating; Translational Research; Translations; cancer type; clinical trial implementation; data management; electronic data; human subject; innovation; novel therapeutics; patient retention; 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.

肿瘤学研究护士协调员是一个亚专科护理角色，负责保障临床试验的完整性，同时平衡临床试验的协调与这些试验中患者的管理。作为一名有执照的专业护士，肿瘤学RNC带来了科学知识，批判性思维技能以及对个人和群体行为的理解的背景。RNC支持广泛的活动，以支持临床研究和患者护理，同时在临床试验开发和实施的每个阶段协助临床研究者。RNC的职责包括患者招募和保留、知情同意、临床试验患者的管理和教育、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、维护详细的监管记录、与执业医师合作、报告不良事件以及确定方案可行性（因为它涉及实施问题）。协议的监管要求已变得更加复杂。RNC有助于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。RNC管理和监控各种电子数据管理系统，并监督数据如何输入系统，验证或清理，传输和编码以及保持安全。RNC在根据方案进行治疗之前、期间和之后识别、监测和报告患者不良事件方面发挥着至关重要的作用。非预期问题的及时提交、严重不良事件的提交和常规不良事件报告均通过RNC进行协调。RNC确保收集准确的数据，并参与定期的质量保证数据监测和审计。作为一名在肿瘤学和研究方面接受过广泛培训的持牌专业护士，RNC在临床研究中发挥着至关重要的作用，并且是从提供患者护理到协调研究到维护临床试验完整性的各个层面的研究行为不可或缺的一部分。研究护理办公室非常重视研究护士协调员作为护理的一个子专业，并根据肿瘤护理学会的临床试验护士模型，框架和能力进行培训和绩效测量。经OAR审查并确定在2019财年保持一致。高度优先的艾滋病毒/艾滋病研究约占该核心预算的10%。CCR医生每年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，用新疗法治疗来自全国各地的数千人。临床研究护士协调员（RNC）的角色是肿瘤学（包括艾滋病相关恶性肿瘤）和艾滋病毒/艾滋病的专业护理角色，对临床试验的有效和安全实施至关重要。RNC在对人类受试者进行研究方面训练有素，除了传统的护理能力外，还在方案可行性和合规性，遵守道德标准，法规要求，数据管理等领域拥有专业知识。该办公室的目标是招聘，培训和保留一个独特的，有凝聚力的团队，由上级研究护士专家组成，他们通过支持继续教育，指导，专业发展和协作的文化来执行CCR的使命，同时平衡全面的患者协调和优质的临床和转化研究。