Protocol Specific Research Support

协议特定研究支持

• 批准号: 7529774
• 负责人: FRANK M. TORTI
• 金额: $ 9.81万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-11 至 2012-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7529774
• 关键词: Adverse event; Appointment; Cancer Center; Clinical; Clinical Nursing; Comprehensive Cancer Center of Wake Forest University; Consent; Data; Data Collection; Data Element; Databases; Detection; Diagnostic tests; Dose; Eagles; Eligibility Determination; Ensure; Evaluation; Face; Funding; Human Resources; In complete remission; Information Systems; Informed Consent; Inpatients; Institution; Intervention Trial; Laboratories; Logistics; Modification; Monitor; Nurses; Nursing Research; Nursing Staff; Outpatients; Patient Recruitments; Patients; Peer Review; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Physicians; Pilot Projects; Printing; Protocol Compliance; Protocols documentation; Quality Control; Randomized; Reporting; Research; Research Ethics Committees; Research Support; Resource Sharing; Resources; Role; Safety; Schedule; Screening procedure; Serious Adverse Event; Services; Source; Specific qualifier value; Support of Research; System; Team Nursing; Technology; Toxic effect; Translating; Visit; Work; Writing; chemotherapy; innovation; member; oncology; patient safety; programs; response; time interval

Protocol Specific Research Support (PSRS) functions include patient recruitment, screening, compliance monitoring, and data collection and dissemination for pilot and innovative CCCWFU institutional studies. The five key functions of the resource follow: 1) Patient Recruitment- Research Nurses evaluate patients (new and existing) for potential protocol eligibility; assist physicians in obtaining all necessary lab work to document eligibility; obtain IRB approved informed consent, work with the Registrar (who verifies eligibility before the accrual is entered into the ORIS database, & ensure that the proper randomization occurs when applicable. 2) Data Capture - All PSRS staff monitor chemotherapy administration, dose modifications, toxicity and patient response; complete all forms (flowsheets) deemed mandatory within the protocol using appropriate source documents; and enter data into the Oncology Research Information System (ORIS) database. The Data Manager uses the ORIS query system to monitor and track requirements for patient data governed by the protocol specific requirements which have been noted in the ORIS database. 3) Protocol Compliance - PSRS staff order appropriate laboratory and diagnostic tests at time intervals specified within the protocol and assist with chemotherapy dose modification when needed to meet protocol requirements. These functions are aided by an ORIS "greensheet" program which generates visit specific requirements, which are printed on "greensheets" and placed on the face of the patient's chart as a reminder to physicians and staff of actions required, and to query physicians during the course of treatment for response, evaluations of toxicity, and any treatment modifications specified in the protocol. 4) Quality Control-The Research Nurses and Data Manager Monitor protocol compliance throughout the course of patient treatment through review of patient charts prior to each scheduled protocol patient visit. This is also done formally at 1st & 3rd patient accrual for institution intervention trials. A review is performed once the first patient is consented to the protocol. The Asst Project Manager (Eagle) and the assigned CRA will check to make sure that all required data elements have been captured. 5) Data and Safety Monitoring - The Research Nurses and Data Manager monitor data collection/reporting and patient safety, acting as the institution and CCCWFU's first detection points for Serious Adverse Events (SAEs). These nurses immediately alert the appropriate PI and Director of CRM and coordinate adverse event tracking reporting with members of CROC and the CRM Shared Resource.

方案特定研究支持(PSR)职能包括患者招募、筛查、遵从性 监测、数据收集和传播，用于试点和创新的CCCWFU机构研究。 该资源的五个主要功能如下： 1)患者招募-研究护士评估患者(新患者和现有患者)的潜在方案 资格；协助医生获得所有必要的实验室工作以证明资格；获得IRB 经批准的知情同意，与注册官合作(注册官在录入应计项目之前核实资格 到Oris数据库，并确保在适当的时候进行适当的随机操作。 2)数据捕获-所有PSRS工作人员监测化疗给药、剂量修改、毒性和 患者回复；填写协议中被认为是强制性的所有表格(流程图) 适当的原始文档；并将数据输入肿瘤学研究信息系统(ORIS) 数据库。数据管理器使用Oris查询系统来监控和跟踪患者的需求 已在Oris数据库中记录的受协议特定要求管辖的数据。 3)协议遵从性-PSRS工作人员每隔一段时间要求进行适当的实验室和诊断测试 在协议中指定，并在需要时协助修改化疗剂量以满足 协议要求。这些功能得到了Oris“GreenSheet”程序的帮助，该程序生成 拜访特定的要求，这些要求印在“绿单”上，并放在病人的脸上 图表，提醒医生和工作人员所需采取的行动，并在 治疗过程中的反应，毒性评估和任何治疗修改 协议。 4)质量控制-研究护士和数据管理员监控整个项目的协议合规性 在每次预定的常规病人探视之前，通过审查病人病历来确定病人的治疗过程。 这也是在机构干预试验的第一和第三患者应计费用时正式完成的。一篇评论是 一旦第一个病人同意了治疗方案，就会立即实施。助理项目经理(鹰)和 分配的CRA将进行检查，以确保已捕获所有必需的数据元素。 5)数据和安全监测--研究护士和数据管理员监测数据收集/报告 和患者安全，作为机构和CCCWFU的严重不良反应的第一个检测点 事件(SAE)。这些护士立即通知适当的PI和客户关系管理总监并协调 与CROC和CRM共享资源的成员进行不良事件跟踪报告。