Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 9981654
• 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
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-05 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9981654
• 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 Reporting; Database Management Systems; 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），以前称为集中方案数据 管理单位（CPDMU），是集中办公室，支持弗雷德和 Pamela Buffett癌症中心（FPBCC），内布拉斯加大学医学中心（UNMC）。OCCR 为制药商发起的试验（IIT）、NCI国家临床试验网络和 合作组试验（联盟主要成员，儿童肿瘤组，NRG）多机构 联盟试验（BIG 10 Cancer Consortium，ACCRU）和行业赞助的研究。联合国的使命 OCCR是协助规划，发展，行为，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。OCCR保证最高 研究质量和遵守相关法规，主要是研究的前期协调， 持续审查研究合规性。OCCR是FPBCC内为调查人员提供的资源 支持所有与癌症相关的临床研究。它由疾病导向小组（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应用程序。OCCR为调查人员提供支持， 研究数据管理，以及方案制定，合作组研究的监测，以及 与联邦和行业赞助商和监管机构的联络。中央档案室为 FPBCC科学审查委员会（SRC）、数据安全监查委员会（DSMC）和稽查 委员会（AC）。OCCR管理临床试验管理系统（CPDM数据库），该系统包含 计划、报告和内部监督以及eCRF开发和研究所需的方案数据 C3 D和MediData RAVE中的数据报告。FPBCC OCCR一直积极参与NCI倡议， 临床试验报告计划（CTRP），并一直是C3 D和Medidata Rave的早期采用者。