CLINICAL RESEARCH OFFICE

临床研究办公室

• 批准号: 7821288
• 负责人: IAN W FLINN
• 金额: $ 77.53万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 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/7821288
• 关键词: Adherence; Adverse event; Amendment; Area; Case Report Form; Clinical Research; Clinical Trials; Collaborations; Communities; Comprehensive Cancer Center; Consent; Data; Databases; Development; Education; Electronics; Environment; Evaluation; Faculty; Human Resources; Intervention; Intervention Trial; Investigational Drugs; Libraries; Malignant Neoplasms; Manuals; Monitor; Nature; Newsletter; Outcome; Performance; Pharmacy facility; Policies; Preparation; Principal Investigator; Procedures; Protocols documentation; Regulation; Reporting; Research; Research Ethics Committees; Research Personnel; Review Committee; Role; Services; Supervision; System; design; meetings; multi-site trial; nurse performance; oncology; programs; quality assurance; research study; web site

The Clinical Research Office (CRO) provides numerous services to faculty and staff conducting oncology research at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) including centralized systems, education, regulatory expertise and quality assurance. Centralized systems are all easily accessible via the CRO website. These systems include an up-to-date protocol library with all approved protocols and consents, a database of all oncology research studies including study accrual and tracking of all IRB submissions, the Clinical Research Review Committee (CRC) Electronic Forum which tracks documents and meeting outcome to support the CRC, a research manual with Standard Operating Procedures, and a pharmacy orders review system for tracking pre-approved orders. Education provided by the CRO includes an introductory research course for all new research staff conducting oncology trials, continuing research education for research faculty and staff, and the "Messenger" newsletter designed to keep research personnel up-to-date with policies and regulations. The CRO provides regulatory expertise in the area of FDA regulations and Investigational New Drug (IND) submissions, and oversight and guidance for all investigator-initiated, multi-site trials. Quality assurance services are an essential component of the CRO via auditing and monitoring, reviewing adverse events, and developing standard operating procedures. Other services offered to investigators include acting as a liaison with the Johns Hopkins Institutional Review Boards, outside auditors, and the SKCCC External Clinical Trials website manager (to promote open trials to the community). Each SKCCC research Program has a Program manager who has a dual reporting role to both the Research Program Directors and the CRO Manager. In 2004, the CRO received 2,401 submissions (new studies, amendments, SAEs, etc). There were 348 active studies in 2004, 76% intervention in nature. This represents a heavy load in an intense regulatory environment where there i increased scrutiny and continuous interactions with the IRB. Accruals in 2004 equaled 3,121; 72% on nonintervention studies and 28% on intervention trials.

临床研究办公室 (CRO) 为从事肿瘤学研究的教职员工提供大量服务 悉尼金梅尔综合癌症中心 (SKCCC) 的研究包括集中式系统、 教育、监管专业知识和质量保证。集中式系统均可通过以下方式轻松访问 克罗网站。这些系统包括一个最新的协议库，其中包含所有批准的协议和 同意书，所有肿瘤学研究的数据库，包括研究应计和所有 IRB 的跟踪 临床研究审查委员会 (CRC) 电子论坛跟踪文件 支持 CRC 的会议成果、包含标准操作程序的研究手册以及 药房订单审查系统用于跟踪预先批准的订单。 CRO 提供的教育包括 为所有进行肿瘤学试验、继续研究的新研究人员开设的介绍性研究课程 对研究教员和工作人员的教育，以及旨在保持研究成果的“信使”通讯 人员了解最新的政策和法规。 CRO 提供以下领域的监管专业知识： FDA 法规和研究性新药 (IND) 提交以及对所有人的监督和指导 研究者发起的多地点试验。质量保证服务是 CRO 的重要组成部分 通过审计和监控、审查不良事件以及制定标准操作程序。 为调查人员提供的其他服务包括充当与约翰霍普金斯大学机构的联络人 审查委员会、外部审计员和 SKCCC 外部临床试验网站管理员（以促进 向社区开放试验）。每个 SKCCC 研究项目都有一名项目经理，他具有双重身份 向研究项目主管和 CRO 经理报告。 2004年，CRO获得 2,401 份提交材料（新研究、修订、SAE 等）。 2004 年有 348 项正在进行的研究，占 76% 对自然的干预。这意味着在严格的监管环境中，我面临着沉重的负担。 加强审查并与 IRB 持续互动。 2004 年应计金额为 3,121； 72% 的人认为不干预 研究和 28% 的干预试验。