Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 9755225
• 负责人: Apar Kishor Ganti
• 金额: $ 9.36万
• 依托单位: UNIVERSITY OF NEBRASKA MEDICAL CENTER
• 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/9755225
• 关键词: Adherence; Amendment; Area; Awareness; Cancer Center; Cancer Center Support Grant; Caring; Catchment Area; Child; Clinical; Clinical Data; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Data; Data Base Management; Data Reporting; Development; Disease; Education; Enrollment; Ensure; Frequencies; Guidelines; Industry; Malignant Neoplasms; Medical center; Medidata; Mission; Monitor; Monitoring Clinical Trials; NCI Center for Cancer Research; 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; Universities; Woman; anticancer research; cancer care; cancer clinical trial; cancer therapy; data management; improved; investigator-initiated trial; member; metropolitan; participant safety; programs; protocol development; quality assurance; recruit; research study; screening; underserved minority

Project Summary/Abstract: Clinical Protocol and Data Management (CPDM) The Office for Cancer Clinical Research (OCCR), previously referred to as the Centralized Protocol Data Management Unit (CPDMU), is the centralized office that supports clinical cancer research in the Fred and Pamela Buffett Cancer Center (FPBCC) at the University of Nebraska Medical Center (UNMC). The OCCR 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 OCCR 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 OCCR 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 OCCR is a resource within the FPBCC to provide investigators support for all cancer-related clinical research. It is composed of disease-oriented teams (DOT'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 OCCR provides investigators with support and study data management, as well as protocol development, monitoring for cooperative group studies, and liaison with federal and industry sponsors and regulatory bodies. The OCCR provides resource support to the FPBCC Scientific Review Committee (SRC), the Data Safety Monitoring Committee (DSMC), and the Audit Committee (AC). The OCCR manages the clinical trials management system (CPDM database) which houses protocol data necessary for planning, reporting and internal oversight, as well as eCRF development and study data reporting in C3D and MediData RAVE. The FPBCC OCCR has been active in NCI initiatives regarding the Clinical Trial Reporting Program (CTRP) and has been an early adopter of C3D and Medidata Rave.

项目摘要/摘要：临床方案和数据管理(CPDM) 癌症临床研究办公室(OCCR)，以前称为集中协议数据 管理单位(CPDMU)是支持弗雷德和霍普金斯大学癌症临床研究的中央办公室 内布拉斯加州大学医学中心(UNMC)的帕梅拉·巴菲特癌症中心(FPBCC)。OCCR 为研究人员发起的试验(IIT)、NCI国家临床试验网络和 合作小组试验(联盟主要成员，儿童肿瘤学小组，NRG)多机构 财团试验(BIG10癌症协会，ACCRU)和行业赞助的研究。世界银行的使命是 OCCR将协助规划、开发、实施、质量保证、监测和遵守 符合监管机构对涉及癌症治疗和护理的临床试验的要求，并提供 对癌症相关人口科学研究的监管支持也是如此。OCCR确保最高 研究的质量和对相关法规的遵守，主要通过研究和前期协调 对研究合规性的持续审查。OCCR是FPBCC内的一个资源，为调查人员提供 支持所有与癌症相关的临床研究。它由以疾病为导向的团队(DOT)组成， 协调研究管理活动(包括筛选受试者、协调治疗和护理，以及 收集和记录研究数据)，以及负责提交 并维护所有监管文件和申请。OCCR为调查人员提供支持和 研究数据管理，以及为合作小组研究制定方案和监测，以及 与联邦和行业赞助商及监管机构保持联系。OCCR为 FPBCC科学审查委员会(SRC)、数据安全监测委员会(DSMC)和审计 委员会(AC)。OCCR管理临床试验管理系统(CPDM数据库) 规划、报告和内部监督以及ECRF发展和研究所需的议定书数据 C3D和Medidata RAVE中的数据报告。FPBCC OCCR一直积极参与NCI的以下倡议 临床试验报告计划(CTRP)是C3D和Medidata Rave的早期采用者。