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CCR Research Nursing

CCR 研究护理

基本信息

批准号：
9556885
负责人：
Caryn Steakley
金额：
$ 925.41万
依托单位：
DIVISION OF BASIC SCIENCES - NCI
依托单位国家：
美国
项目类别：
财政年份：
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/9556885
关键词：
Adherence Adverse event Area Basic Science Behavior 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 Development Discipline of Nursing Documentation Education Ensure Equilibrium Ethics Individual Information Technology Informed Consent Knowledge Maintenance Maryland Measurement Medical Mentorship Mission Monitor Nurse&apos s Role Nurses Nursing Models Nursing Research Nursing Societies Nursing Specialties Oncology Nurse Patient Care Patient Recruitments Patients Performance Phase Physicians Play Prevention strategy Protocol Compliance Protocols documentation Records Recruitment Activity Reporting Research Role Safety Secure Serious Adverse Event Specialist System Time Training Translating Translational Research Translations Vision base cancer type cohesion data management electronic data human subject innovation novel therapeutics oncology programs quality assurance skills

项目摘要

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.

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执业专业护士，RNC在临床研究中发挥着至关重要的作用，并且是各个层面研究行为不可或缺的一部分，从提供患者护理到协调研究，再到维护临床试验的完整性。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评估。