CLINICAL RESEARCH OFFICE

临床研究办公室

• 批准号: 8117664
• 负责人: IAN W FLINN
• 金额: $ 76.48万
• 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/8117664
• 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）为进行肿瘤学的教职员工提供了许多服务 Sidney Kimmel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。集中式系统都可以轻松地通过 CRO网站。这些系统包括具有所有批准协议的最新协议库， 同意，这是所有肿瘤研究研究的数据库，包括研究和跟踪所有IRB 提交，临床研究审查委员会（CRC）电子论坛，该论坛跟踪文件 并达到支持CRC的结果，具有标准操作程序的研究手册， 药房订单审查系统，用于跟踪预批准的订单。 CRO提供的教育包括 所有进行肿瘤学试验的新研究人员的入门研究课程，继续研究 研究教师和员工的教育以及旨在保持研究的“使者”新闻通讯 最新的政策和法规的人员。 CRO在该领域提供了监管专业知识 FDA法规和研究新药（IND）提交，以及所有人的监督和指导 研究人员发射的多站点试验。质量保证服务是CRO的重要组成部分 通过审核和监视，审查不良事件以及制定标准操作程序。 提供给调查人员的其他服务包括与约翰·霍普金斯机构的联络 审查委员会，外部审计师和SKCCC外部临床试验网站经理（促进 向社区开放试验）。每个SKCCC研究计划都有一个具有双重的计划经理 向研究计划董事和CRO经理报告角色。 2004年，CRO收到了 2,401项提交（新研究，修正案，SAE等）。 2004年有348项主动研究，76％ 干预自然。这代表了我那里的强烈监管环境中的重负荷 增加了与IRB的审查和连续相互作用。 2004年的应计等于3,121；不干预的72％ 研究和28％的干预试验。