Clinical Support

临床支持

• 批准号: 8344994
• 负责人: Richard Cannon
• 金额: $ 403.94万
• 依托单位: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
• 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/8344994
• 关键词: Appointment; Archives; Biometry; Budgets; Clinical; Clinical Research; Clinical Research Protocols; Clinical Trials Data Monitoring Committees; Conflict of Interest; Consent; Contracts; Credentialing; Data; Electronics; Enrollment; Ensure; Ethics; Financial compensation; Human Subject Research; Institutional Review Boards; Life Cycle Stages; Mandatory Reporting; Medical Staff; Monitor; National Heart, Lung, and Blood Institute; Nurses; Patient Recruitments; Patients; Performance; Policies; Process; Protocols documentation; Reporting; Research; Research Personnel; Research Training; Serious Adverse Event; Services; System; Travel; cost; data management; protocol development; response; web site

The Office of the Clinical Director includes the Office of Clinical Affairs for protocol, IRB and DSMB support, and prtocol monitors and FDA regulatory expertise under contract with SAIC-Frederick. Activities of the Office include receipt of protocols by an electronic submission system, selecting scientific and biostatistic reviewers, performing a pre-IRB review of content and organization, submission to IRB after satisfactory responses from investigators and submittint approved protocol to the Office of Protocol Service. The Office also interacts with eth Office of Human Subjects Research Protections, especially regarding unexpected serious adverse events possible related to research participation. In the comining year, the Office will also provide protocol navigators and data managers to research teams.

临床主任办公室包括临床事务办公室，负责方案、IRB 和 DSMB 支持，以及根据与 SAIC-Frederick 签订的合同监测方案和 FDA 监管专业知识。该办公室的活动包括通过电子提交系统接收方案、选择科学和生物统计审查员、对内容和组织进行预 IRB 审查、在调查人员做出满意答复后向 IRB 提交并向礼宾服务办公室提交批准的方案。该办公室还与人类受试者研究保护办公室进行互动，特别是在可能与研究参与相关的意外严重不良事件方面。在来年，该办公室还将为研究团队提供协议导航器和数据管理器。