Clinical Nursing and Data Management Core

临床护理和数据管理核心

• 批准号: 7733484
• 负责人: William Marston Linehan
• 金额: $ 85.54万
• 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/7733484
• 关键词: Admission activity; Affect; Amendment; Appointment; Appointments and Schedules; Bilateral; Blood; Businesses; Cancer Patient; Cancer-Predisposing Gene; Cardiology; Clinical; Clinical Management; Clinical Nursing; Clinical Nursing Research; Clinical Research; Clinical Trials; Communication; Communities; Complement 3d; Complex; Condition; Conduct Clinical Trials; Consent; Consult; Consultations; Contracts; Counseling; DNA; Data; Databases; Dermatology; Development; Diagnosis; Discipline of Nursing; Disease; Education; Educational Materials; Educational process of instructing; Eligibility Determination; Endocrine; Enrollment; Evaluation; Family; Family Study; Film; Follow-Up Studies; Generations; Genetic; Genetic Predisposition to Disease; Genetic screening method; Genotype; Goals; Guidelines; Health Promotion; Heart; Human; Human Resources; Humanities; Image; Informed Consent; Inherited; Intake; Internal Medicine; Kidney Neoplasms; Knowledge; Leiomyomatosis; Letters; Localized; MRI Scans; Magnetic Resonance Imaging; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of kidney; Malignant neoplasm of prostate; Malignant neoplasm of urinary bladder; Measurement; Medical; Medical History; Medical Records; Medical Surveillance; Mentors; Mentorship; Methods; Modality; Modeling; Natural History; Neurology; Nurses; Nursing Research; Operating Rooms; Operative Surgical Procedures; Paper; Papillary; Patient Admission; Patient Appointment; Patient Care; Patient Education; Patient Recruitments; Patient Schedules; Patients; Persons; Physician Assistants; Physicians; Policies; Positron-Emission Tomography; Postoperative Period; Practice Guidelines; Predisposition; Principles of law and justice; Procedures; Process; Professional Practice; Professional counselor; Prostate; Protocols documentation; Purpose; Quality of life; Questionnaires; Recommendation; Recruitment Activity; Renal Cell Carcinoma; Renal carcinoma; Reporting; Research; Research Ethics Committees; Resources; Risk; Schedule; Scientist; Services; Slide; Social Work; Societies; Specialist; Support Groups; Support of Research; Surgeon; Syndrome; System; Telephone; Test Result; Time; Tissue Procurements; Tissues; Travel; United States National Institutes of Health; Urine; Urologic Cancer; Urologic Oncology; Urology; Visit; Work; Writing; X-Ray Computed Tomography; bone imaging; compliance behavior; data integrity; data management; demographics; diaries; follow-up; genetic pedigree; human subject; member; novel; patient expectation; programs; psychosocial; success; text searching; tumor

The heart of the Urologic Oncology Branch is our clinical program- we study the human model of kidney cancer, prostate cancer and bladder cancer. The Urologic Oncology Clinical Core is comprised of a genetic counselor / protocol manager, clinical research nurses, patient care coordinators (PCC), a senior data manager and data managers. RESEARCH NURSES Clinical trials Research nurse specialists coordinate / manage the operations of our clinical trials in kidney cancer, prostate cancer and bladder cancer. Their responsibilities include: kidney cancer, prostate cancer and bladder cancer patient recruitment, participate in the informed consent process; perform patient education; create patient-specific protocol schedule; schedule blood and urine studies, CT scan, MRI; PET CT, internal medicine, neurosurgical, ENT consults; register patient with CRO; collect / review diaries with patients; assess patient compliance; rapid and accurate data capture; Q/A data entries in c3D; report AEs to NCI IRB and sponsor according to protocol requirements; submit annual Continuing Reviews to IRB; maintain regulatory binder; participate in clinical trial meetings. Familial Kidney Cancer A key component of the UOB Branch is the study of families who have rare inherited conditions, such as von Hippel-Lindau, Hereditary Papillary Renal Cell Cancer, Birt-Hogg-Dub Syndrome, and Hereditary Leiomyomatosis and Renal Cell Carcinoma, which predispose to development of kidney cancer. Research nurse specialists and a genetic counselor provide protocol oversight for our natural history protocols in kidney cancer, prostate cancer and bladder cancer. Responsibilities include: patient recruitment; telephone intake covering pedigree; initiation of informed consent process to include purpose of study; provide information about NIH, the study objectives, assess patients expectations; initial medical history; determine appropriate clinical studies; communicate with Patient Care Coordinators (PCC) re: appointment and indicated studies; assist PCC in obtaining pertinent medical records; tissue slides, films; obtain informed consent; assure patient has adequate understanding of information received during visit; prepare / submit annual Continuing Review to NCI IRB. Prostate Cancer and Bladder Cancer The prostate cancer and bladder cancer program is supported by research nurse specialists who have overall oversight of patients with localized prostate or bladder cancer. Responsibilities include: telephone intake to include; purpose of study; information about NIH, the study objectives, assess patients expectations; initial medical history; initiate informed consent process; determine appropriate clinical studies; communicate with Patient Care Coordinators (PCC) re: appointment and indicated studies; obtain informed consent in person ; patient teaching; follow-up visit; assure Quality of Life questionnaires are submitted /received by patients at multiple time points; work with data managers to assure data is captured and submitted. GENETIC COUNSELING A Genetic Counselor actively participates in pursuit of the research questions about known genetic syndromes or unknown familial renal cancer. Responsibilities include: family recruitment through professional genetic societies; develop a 3-generation pedigree; complete a personal medical history; determine the genetic test to be performed; perform literature searches, contribute to the identification of novel clinical manifestations of rare heritable malignant disorders. Patients with or at risk for an inherited kidney cancer cancer susceptibility disorder undergo an extensive counseling / education session. Topics generally covered during these sessions include: Clinical aspects and natural history of the suspected disorder; if the disorder is unknown, the differential, clinical and genetic evaluation plan is presented; psychosocial risks of genetic testing; implications of potential genetic test results; clinical management of condition and /or multiple, bilateral renal tumors; health promotion strategies; provide supportive counseling at-risk or affected patients; provide written educational material and medical papers if appropriate; provide information about support groups; discuss familial communication. Genetic test results are provided per patient preferred modality; a counseling letter is sent with DNA result and recommended surveillance strategies. PROTOCOL MANAGER Overall protocol management is the responsibility of our Genetic Counselor. Protocol manager responsibilities include: draft natural history protocols; prepare and submit protocol amendments; submit Continuing Reviews for natural history and tissue procurement protocols; remain informed about the IRB process as well as the ethical / legal aspects of clinical research; serve as a resource/ mentor to the UOB about protocols and the IRB process PHYSICIANS ASSISTANT The in-patient and Urology consult service is managed by our Physician Assistant (P.A.). Responsibilities include: manage surgical patients upon decision for surgery; determine with surgical Fellows, the appropriate pre-operative work-up; arrange in-patient admission; schedule / enter orders for operative admission including imaging studies, consultations; refer patients to NIH social service for potential Family Lodge availability; perform H & P upon admission; conduct regular and frequent patient rounds; handle patient concerns while surgeons in operating room; schedule post-operative follow up visit; collaborate with nursing /social service re: discharge plan; see consult patient during post-op visit. The Urology consult service, offered to the entire NIH community is managed by our P.A. Responsibilities include: initially see / evaluate all consult patients; assess patient and, in concert with UOB Fellows, identify probable diagnosis; recommendations to referring service; see all consults at follow-up visits; submit consult note into CRIS system. PATIENT CARE COORDINATORS The complex task of scheduling multiple appointments and clinical studies is the responsibility of our patient care coordinators (PCC). PCC responsibilities include: schedule new and follow- up patient appointments; communicate with patients regarding reimbursement / travel policy; admission procedures; enter patient information into ATV system; schedule all studies such as CT, MRI. bone scan, PET CT; arrange coordinate consultations with internal medicine, neurology, endocrine, dermatology, cardiology consults, etc.; develop patient schedule; send letter of invitation; copy of protocol consent, appointment schedule; obtain relevant tissue slides, imaging studies and medical records; track / oversee recommendation by UOB physicians for follow-up visits and recommended studies for follow-up visits. DATA MANAGEMENT Senior Data Manager Overall management of UOB data is the responsibility of our senior Data Manager. His responsibilities include: adapt LabMatrix to UOB data needs; maintain extensive UOB database; responsible for data integrity; query requested reports; Q/A entered data; capture and track: demographics; tumor measurements; clinical manifestations; genetic test results / genotype; provide mentorship to contract data personnel. Data management staff: One data management [summary truncated at 7800 characters]

泌尿肿瘤科的核心是我们的临床项目——我们研究肾癌、前列腺癌和膀胱癌的人类模型。泌尿肿瘤临床核心由遗传咨询师/方案经理、临床研究护士、患者护理协调员 (PCC)、高级数据经理和数据经理组成。研究护士 临床试验 研究护士专家协调/管理我们肾癌、前列腺癌和膀胱癌临床试验的运作。他们的职责包括：招募肾癌、前列腺癌和膀胱癌患者，参与知情同意过程；进行患者教育；创建针对患者的方案时间表； 安排血液和尿液检查、CT 扫描、MRI； PET CT、内科、神经外科、耳鼻喉科会诊；向 CRO 登记患者；收集/审查患者的日记；评估患者的依从性；快速准确的数据采集； c3D 中的 Q/A 数据条目；根据方案要求向 NCI IRB 和申办者报告 AE；向 IRB 提交年度持续审查； 维持监管活页夹；参加临床试验会议。家族性肾癌 大华银行分支的一个重要组成部分是对患有罕见遗传性疾病的家庭进行研究，例如 von Hippel-Lindau、遗传性乳头状肾细胞癌、Birt-Hogg-Dub 综合征以及遗传性平滑肌瘤病和肾细胞癌，其中易患肾癌。研究护士专家和遗传咨询师为我们的肾癌、前列腺癌和膀胱癌自然史方案提供方案监督。 职责包括： 招募患者；电话受理涵盖血统；启动知情同意程序以包括研究目的；提供有关 NIH、研究目标的信息，评估患者的期望；初始病史；确定适当的临床研究；与患者护理协调员 (PCC) 就预约和指定研究进行沟通；协助PCC获取相关医疗记录；组织切片、胶片； 获得知情同意；确保患者充分理解就诊期间收到的信息；准备/向 NCI IRB 提交年度持续审查。前列腺癌和膀胱癌 前列腺癌和膀胱癌计划由研究护士专家支持，他们对局部前列腺癌或膀胱癌患者进行全面监督。 职责包括： 电话受理；学习目的；有关 NIH 的信息、研究目标、评估患者的期望；初始病史；启动知情同意程序；确定适当的临床研究；与患者护理协调员 (PCC) 就预约和指定研究进行沟通；亲自获得知情同意；耐心教导；随访；确保患者在多个时间点提交/收到生活质量调查问卷；与数据经理合作，确保捕获和提交数据。遗传咨询 遗传咨询师积极参与有关已知遗传综合征或未知家族性肾癌的研究问题。职责包括：通过专业遗传协会进行家庭招募； 发展第三代血统；填写个人病史；确定要进行的基因测试；进行文献检索，有助于识别罕见遗传性恶性疾病的新临床表现。患有遗传性肾癌癌症易感性疾病或有遗传性肾癌癌症易感性疾病风险的患者接受广泛的咨询/教育课程。这些会议通常涵盖的主题包括：疑似疾病的临床方面和自然史；如果疾病未知，则提出鉴别、临床和遗传评估计划；基因检测的心理社会风险； 潜在基因测试结果的影响；病情和/或多发性双侧肾肿瘤的临床管理；健康促进策略；为高危或受影响的患者提供支持性咨询；如果合适的话，提供书面教育材料和医学论文；提供有关支持团体的信息；讨论家庭沟通。根据患者首选的方式提供基因检测结果；我们将发送一封咨询信，其中包含 DNA 结果和建议的监测策略。方案经理 整体方案管理由我们的遗传顾问负责。协议经理的职责包括：起草自然历史协议；准备并提交方案修正案；提交自然历史和组织采购协议的持续审查；随时了解 IRB 流程以及临床研究的伦理/法律方面的信息；担任大华银行关于方案和 IRB 流程的资源/导师 医师助理 住院和泌尿科咨询服务由我们的医师助理 (P.A.) 管理。职责包括： 根据手术决定管理手术患者；与外科研究员一起确定适当的术前检查；安排住院；安排/输入手术入院指令，包括影像学检查、咨询；将患者转介至 NIH 社会服务处，了解可能有家庭旅馆的情况；入院时进行 H&P；定期、频繁地查房；外科医生在手术室时处理患者的疑虑； 安排术后随访；与护理/社会服务部门合作：出院计划；请在术后访视期间咨询患者。为整个 NIH 社区提供的泌尿科咨询服务由我们的 P.A. 管理。职责包括： 初步查看/评估所有咨询患者；评估患者，并与大华银行研究员合作，确定可能的诊断；对转介服务的建议；查看随访时的所有咨询；将咨询记录提交至 CRIS 系统。患者护理协调员 安排多次预约和临床研究的复杂任务是我们的患者护理协调员 (PCC) 的责任。 PCC 的职责包括： 安排新的和后续的患者预约；与患者沟通报销/差旅政策；入学手续；将患者信息输入ATV系统；安排所有检查，如 CT、MRI。 骨扫描、PET CT；安排内科、神经内科、内分泌科、皮肤科、心脏病科等的协调会诊；制定患者时间表；发送邀请函；协议同意书、预约时间表的副本；获取相关组织切片、影像学研究和医疗记录；跟踪/监督大华银行医生对随访就诊的推荐以及对随访就诊推荐的研究。数据管理 高级数据经理 大华银行数据的整体管理由我们的高级数据经理负责。他的职责包括：使 LabMatrix 适应 UOB 数据需求；维护广泛的大华银行数据库； 负责数据完整性；查询请求的报告； Q/A 输入的数据；捕获和跟踪：人口统计数据；肿瘤测量；临床表现；基因检测结果/基因型； 为合同数据人员提供指导。资料管理人员：资料管理一名【摘要截断至7800字符】