Clinical Nursing and Data Management Core

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体模型。泌尿外科肿瘤临床核心由一名遗传咨询师/方案经理、临床研究护士、患者护理协调员（PCC）、一名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/管理我们在肾癌，前列腺癌和膀胱癌的临床试验的操作。他们的职责包括：肾癌、前列腺癌和膀胱癌患者的招募，参与知情同意过程；进行患者教育；创建针对患者的协议时间表；安排血尿检查、CT扫描、MRI检查；PET CT、内科、神经外科、耳鼻喉科会诊；注册CRO患者；收集/回顾患者日记；评估患者依从性；快速准确的数据采集；c3D中的Q/A数据条目；根据协议要求向NCI IRB和赞助商报告ae；向审核委员会提交年度持续检讨；保持法规绑定；参加临床试验会议。家族性肾癌大华银行分支的一个关键组成部分是研究具有罕见遗传性疾病的家族，如von Hippel-Lindau，遗传性乳头状肾细胞癌，Birt-Hogg-Dub综合征，遗传性平滑肌瘤病和肾细胞癌，这些疾病易患肾癌。研究护士专家和遗传咨询师为我们的肾癌、前列腺癌和膀胱癌的自然病史协议提供协议监督。职责包括：患者招募；电话摄入量涵盖谱系；启动知情同意程序，包括研究目的；提供有关NIH的信息，研究目标，评估患者期望；初始病史；确定适当的临床研究；与患者护理协调员（PCC）就预约和指示性研究进行沟通；协助PCC取得有关的医疗纪录；组织载玻片、薄膜；获得知情同意；确保患者对就诊期间收到的信息有充分的了解；准备/提交年度持续评审给NCI IRB。前列腺癌和膀胱癌项目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：电话接听包括；研究目的；有关NIH的信息，研究目标，评估患者期望；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）就预约和指示性研究进行沟通；亲自取得知情同意；病人的教学;后续访问;确保患者在多个时间点提交/接收生活质量问卷；与数据经理合作，确保数据被捕获和提交。遗传咨询遗传咨询师积极参与已知遗传综合征或未知家族性肾癌的研究问题。职责包括：通过专业遗传学会进行家庭招募；发展3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，有助于发现罕见的遗传性恶性疾病的新临床表现。患有或有患遗传性肾癌易感性疾病风险的患者需要接受广泛的咨询/教育。在这些会议期间通常涉及的主题包括：临床方面和疑似疾病的自然史；如果疾病未知，则提出鉴别、临床和遗传评估计划；基因检测的社会心理风险；潜在基因检测结果的影响；单发和/或多发双侧肾肿瘤的临床处理促进健康战略；为高危患者或受影响患者提供支持性咨询；酌情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。基因检测结果按患者偏好的方式提供；发送一封咨询信，其中包含DNA结果和建议的监测策略。总体方案管理是我们的遗传咨询师的责任。协议经理的职责包括：起草自然历史协议；编写和提交议定书修正案；提交自然史和组织采购方案的持续审查；继续了解IRB程序以及临床研究的伦理/法律问题；作为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外科咨询服务由我们的医师助理（P.A.）管理。职责包括：对手术患者进行手术决策管理；与外科研究员一起确定适当的术前检查；安排住院病人入院；安排/输入手术入院订单，包括影像学检查、会诊；将患者转介到NIH社会服务部门，了解是否有可能提供家庭旅馆；入院时执行H &amp； P；进行定期和频繁的查房；当外科医生在手术室时，处理病人的问题；安排术后随访；配合护理/社会服务部门制定出院计划；见术后访视时咨询患者。泌尿科咨询服务，提供给整个NIH社区是由我们的私人助理管理的职责包括：初步看到/评估所有会诊患者；评估病人，并与大华银行研究员合作，确定可能的诊断；转介服务建议；在随访时见到所有会诊医生；向CRIS系统提交咨询说明。安排多个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：安排新病人和跟进病人的预约；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；安排所有的研究，如CT， MRI。骨扫描，PET CT；安排内科、神经内科、内分泌科、皮肤科、心脏科等会诊；制定病人时间表；发送邀请函；协议同意书副本，预约时间表；获取相关组织切片、影像学检查和医疗记录；跟踪/监督大华银行医生对随访的建议和对随访的推荐研究。数据管理高级数据经理全面管理大华银行的数据是我们高级数据经理的职责。他的职责包括：调整LabMatrix以满足大华银行的数据需求；维护广泛的大华银行数据库；负责数据的完整性；查询请求的报告；Q/A输入数据；捕获和跟踪：人口统计；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。数据管理人员：1名数据管理人员负责跟踪/识别肿瘤大小和位置；肿瘤生长速度；为大华银行档案捕获图像。两名合约数据职员负责输入/ QA从自然历史收集的数据[摘要截短为7800字]

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 staff is responsible for tracking/ identifying tumor size and location; growth rates of tumors; captures images for UOB archives. Two contract data staff members are responsible for entering / QA data collected from natural history [summary truncated at 7800 characters]