Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10491779
• 负责人: Apar Kishor Ganti
• 金额: $ 13.39万
• 依托单位: UNIVERSITY OF NEBRASKA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-05 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10491779
• 关键词: Adherence; Amendment; Area; Awareness; Cancer Center; Cancer Center Support Grant; Caring; Case Report Form; Catchment Area; Child; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Data; Data Reporting; Development; Disease; Education; Enrollment; Ensure; Frequencies; Guidelines; Industry; Malignant Neoplasms; Minority Groups; Mission; Monitor; Monitoring Clinical Trials; National Clinical Trials Network; Nebraska; Office Management; Pediatric Oncology Group; Phase; Population; Population Sciences; Procedures; Process; Protocols documentation; Regulation; Reporting; Research; Research Personnel; Research Support; Resources; Review Committee; Rural Population; Safety; Serious Adverse Event; Site; System; Time; Training and Education; Woman; anticancer research; cancer care; cancer clinical trial; cancer therapy; clinical trial implementation; data management; electronic data; improved; investigator-initiated trial; member; metropolitan; participant safety; programs; protocol development; quality assurance; recruit; research study; screening; underserved minority

PROJECT SUMMARY: CLINICAL PROTOCOL AND DATA MANAGEMENT The Fred & Pamela Buffett (BCC) Clinical Trials Office (CTO), previously referred to as the Centralized Protocol Data Management Unit (CPDMU), is the centralized office which supports clinical cancer research in the Cancer Center. The BCC CTO provides centralized support for investigator-initiated trials (IIT), NCI National Clinical Trials Network and cooperative group trials (Main Member of Alliance, Children's Oncology Group, NRG) multi-institutional consortium trials (BIG10 Cancer Consortium, ACCRU) and industry-sponsored studies. The mission of the BCC CTO is to assist with the planning, development, conduct, quality assurance, monitoring and compliance of with regulatory agency requirements for clinical trials involving cancer treatments and care, and to provide regulatory support for cancer-related population science studies as well. The BCC CTO assures the highest quality of research and adherence to relevant regulations by primary upfront coordination of the study and ongoing review of research compliance. The BCC CTO is the resource within the Cancer Center, which provides support to investigators for all cancer clinical research. It is organized by disease-focused teams (DFT's) that coordinate study management activities, including screening subjects; coordination of treatment and care; and collecting and recording study data; as well as the regulatory management teams responsible for submitting and maintaining all regulatory documents and applications. The BCC CTO provides BCC investigators support for protocol development, data management, monitoring for cooperative group studies, and liaison with federal and industry sponsors and regulatory bodies. The BCC CTO also provides support to the BCC Scientific Review Committee (SRC), the Data Safety Monitoring Committee (DSMC), and the Audit Committee (AC). The BCC CTO manages the clinical trials management system (OnCore) which houses protocol data necessary for planning, reporting and internal oversight, as well as the development of electronic case report forms (eCRF) and study data reporting in Forte EDC (Electronic Data Capture). The BCC CTO has been active in NCI initiatives regarding Clinical Trial Reporting Program (CTRP).

项目摘要：临床协议和数据管理 Fred＆Pamela Buffett（BCC）临床试验办公室（CTO），以前称为集中式 协议数据管理单元（CPDMU）是集中办事处，支持临床癌症研究 癌症中心。 BCC CTO为调查员发起的试验（IIT）提供集中支持 临床试验网络和合作小组试验（NRG儿童肿瘤学集团联盟的主要成员） 多机构财团试验（BIG10癌症联盟，ACCRU）和行业赞助的研究。这 BCC CTO的使命是协助计划，开发，行为，质量保证，监视和 遵守涉及癌症治疗和护理的临床试验的监管机构要求，以及 为与癌症相关的人群科学研究提供监管支持。 BCC CTO确保 研究的最高质量研究和对相关法规的遵守。 以及正在进行的研究合规性审查。 BCC CTO是癌症中心的资源，该资源 为所有癌症临床研究提供了研究人员的支持。它由以疾病为中心的团队（DFT）组织 协调研究管理活动，包括筛查主题；治疗和护理的协调； 并收集和记录研究数据；以及负责提交的监管管理团队 并维护所有监管文件和应用。 BCC CTO为BCC调查人员提供支持 用于协议开发，数据管理，合作小组研究的监视以及与联邦的联络 以及行业赞助商和监管机构。 BCC CTO还为BCC科学提供了支持 审查委员会（SRC），数据安全监测委员会（DSMC）和审计委员会（AC）。 BCC CTO管理临床试验管理系统（ON -CORE），该系统包含必要的协议数据 用于计划，报告和内部监督以及电子案例报告表（ECRF）的开发 并研究FORTE EDC（电子数据捕获）中的数据报告。 BCC CTO已活跃于NCI计划 关于临床试验报告计划（CTRP）。