Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10395527
• 负责人: Kevin Knudtson
• 金额: $ 25.77万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-07-14 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10395527
• 关键词: Adherence; Biometry; Cancer Center Support Grant; Clinical; Clinical Cancer Center; Clinical Data; Clinical Investigator; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Comprehensive Cancer Center; Consent; Data; Data Collection; Development; Disease; Education; Eligibility Determination; Enrollment; Ensure; Evaluation; Feedback; Funding; Industry; Informed Consent; Infrastructure; Institutional Review Boards; Intervention; Medical; Mentorship; Mission; Modification; Molecular Epidemiology; Monitor; Monitoring Clinical Trials; National Clinical Trials Network; Oncology Group; Participant; Patients; Phase; Protocols documentation; Radiology Specialty; Reporting; Research Personnel; Resources; Review Committee; Route; Safety; Schedule; Services; System; Toxic effect; Work; adverse event monitoring; anticancer research; base; career; data management; improved; innovation; investigator-initiated trial; multidisciplinary; participant safety; protocol development; quality assurance; quantitative imaging; response; safety study; screening; translational cancer research

CPDM PROJECT SUMMARY/ABSTRACT The Clinical Protocol and Data Management (CPDM) efforts of the Holden Comprehensive Cancer Center (HCCC) are managed through two related components – Clinical Research Services (CRS) and Data and Safety Monitoring (DSM). These components have grown and strengthened significantly over the prior funding period. They are critical to the mission of the HCCC and support HCCC clinical cancer research including treatment, non-treatment interventional and non-interventional studies. They encompass clinical research, regulatory, and data and safety monitoring. This includes investigator-initiated trials (IITs), National Clinical Trials Network (NCTN) trials, consortium trials, and industry sponsored trials. Services provided by the CRS related to protocol management include protocol selection, development, routing, modification and adverse event monitoring. The CRS also provides trial specific support through staff that assist in assignment of trials to teams, protocol listing and promotion, accrual tracking, assistance with screening and consenting subjects, data management, quality assurance, and education for early career clinical investigators. The CRS works closely with other shared research resources to support translational cancer research, particularly Biostatistics (Biostats) and the Biospecimens Procurement and Molecular Epidemiology Resource (BioMER). A new component of the CRS is the Radiology Core Lab (RCL) that provides quantitative imaging services for clinical trials. DSM is coordinated through HCCC’s DSM Committee. The DSM has a distinct function from the Protocol Review and Monitoring Committee and IRB. DSM focuses on IITs and ensures the development of an acceptable data and safety monitoring plan, assesses subject safety, monitors clinical trial data veracity and protocol adherence, and provides education to investigators. CPDM also solicits feedback and responds to that feedback by providing innovative infrastructure that meets the needs of clinical investigators.

CPDM项目摘要/摘要 霍顿综合癌症中心的临床方案和数据管理（CPDM）工作 （HCCC）通过两个相关组件进行管理 - 临床研究服务（CRS）和数据以及 安全监控（DSM）。这些组件在先前的资金上已经大大增长和增强 时期。它们对HCCC的使命至关重要，并支持HCCC临床癌症研究 治疗，非治疗介入和非惯例研究。他们包括临床研究， 监管，数据和安全监控。这包括研究人员发起的试验（IIT），国家临床 试验网络（NCTN）试验，财团试验和行业赞助的试验。 CRS提供的服务 与协议管理相关的包括协议选择，开发，路由，修改和不利 事件监视。 CRS还通过员工提供特定的试验支持，以帮助分配试验 团队，协议上市和促销，审议跟踪，筛查和同意主题的协助， 早期职业临床研究人员的数据管理，质量保证和教育。 CRS起作用 与其他共享的研究资源紧密联系，以支持翻译的癌症研究，尤其是生物统计学 （Biostats）以及生物测量的采购和分子流行病学资源（BioMer）。一个新 CRS的组成部分是放射学核心实验室（RCL），可为临床提供定量成像服务 试验。 DSM通过HCCC的DSM委员会协调。 DSM与 协议审查和监测委员会和IRB。 DSM专注于IIT，并确保开发 可接受的数据和安全监控计划，评估主题安全，监视临床试验数据真实性和 协议依从性，并向调查人员提供教育。 CPDM还固定反馈和对此的反应 通过提供满足临床研究人员需求的创新基础设施来反馈。