Protocol Specific Research Support

方案特定研究支持（PSRS）功能包括患者招募、筛选、依从性 监测、数据收集和传播，以进行试点和创新性的CCCWFU机构研究。 该资源的五项主要职能如下： 1)患者招募-研究护士评估患者（新的和现有的）的潜在方案 合格性;协助医生获得所有必要的实验室工作，以记录合格性;获得IRB 经批准的知情同意书，与登记员合作（登记员在输入应计费用之前验证资格 输入ORIS数据库，并确保在适用时进行适当的随机化。 2)数据采集-所有PSRS工作人员监测化疗给药、剂量调整、毒性和 患者反应;使用以下表格填写方案中视为强制性的所有表格（流程图） 适当的源文件;并将数据输入肿瘤学研究信息系统（ORIS） 数据库数据管理员使用ORIS查询系统监控和跟踪患者需求 受方案特定要求控制的数据，已在ORIS数据库中记录。 3)方案合规性-PSRS工作人员按时间间隔安排适当的实验室和诊断检测 并在需要时协助调整化疗剂量，以满足 方案要求。这些功能由ORIS "greensheet"程序辅助， 访问的具体要求，这是印在"绿单"，并放置在病人的脸上， 图表作为医生和工作人员所需行动的提醒，并在 治疗过程中的反应，毒性评价，和任何治疗调整中规定的 议定书 4)质量控制-研究护士和数据经理在整个过程中监测方案合规性 在每次计划的方案患者访视前，通过审查患者病历了解患者治疗过程。 这也是在机构干预试验的第1和第3例患者招募时正式完成的。由于审阅 一旦第一位患者同意该方案，就执行该方案。助理项目经理（鹰）和 指定的CRA将进行检查，以确保已捕获所有必需的数据元素。 5)数据和安全性监测-研究护士和数据经理监测数据收集/报告 和患者安全，作为机构和CCCWFU的严重不良事件的第一检测点 事件（SAE）。这些护士立即通知相应的PI和CRM总监， 与CROC成员和CRM共享资源一起进行不良事件跟踪报告。

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.