Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10212291
• 负责人: Jennifer Keating Litton
• 金额: $ 69.64万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-08-28 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10212291
• 关键词: Accountability; Aman; Businesses; Cancer Center Support Grant; Child; Clinical Data; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Complement; Computer Systems; Conduct Clinical Trials; Data; Development; Disease; Electronic Health Record; Enrollment; Ensure; Ethics; Evaluation; Future; Goals; Grant; Home; Infrastructure; Institution; Institutional Review Boards; Intervention; Lead; Legal; Link; Longevity; Minority; Monitor; Multi-Institutional Clinical Trial; National Clinical Trials Network; Occupational activity of managing finances; Online Systems; Participant; Patients; Pediatric Oncology; Performance; Positioning Attribute; Process; Protocols documentation; Ramp; Request for Proposals; Research; Research Infrastructure; Research Personnel; Safety; Services; Site; Structure; Support System; System; Time; Woman; data management; data resource; education research; human subject; improved; industry partner; organizational structure; programs; recruit; safety study; systems research

ABSTRACT CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) The overall goal of Clinical Protocol and Data Management (CPDM) is to provide high-quality infrastructure support for all aspects of clinical protocol research at MD Anderson. The services of the CPDM, directed by Dr. Aman Buzdar, Associate Director for Clinical Research Administration, include support of single- and multi- center clinical trials through the protocol lifespan; human subject/clinical research education; auditing and monitoring active clinical trials; assuring regulatory compliance of IND studies; facilitating protocol financial management; and supporting biospecimen research. The CPDM complements the activities of the Protocol Review and Monitoring System (PRMS) by supporting the electronic protocol submission and evaluation processes. A Protocol Systems Legacy Refresh Project (PSLR) was undertaken in 2016 to migrate functionality of the legacy systems to a more contemporary, stable platform. The new electronic health record (EHR) system OneConnect (Epic), launched in March 2016, provides an integrated clinical, research, and business platform, with 2,188 interventional protocols and 102,134 patients now linked to the EHR. During the last 6 years, the total number of protocols managed by CPDM has increased from 5,018 in FY2012 to 5,974 in FY2017 (an increase of 19%). New patient registrations to interventional and non-interventional trials have averaged about 35,000 per year; however, a significant reduction was noted in the level of FY2016 and FY2017 accruals (24,676 and 26,568, respectively), largely due to efforts made to ensure a smooth implementation of OneConnect. Importantly, MD Anderson investigators have enrolled 739 patients to the NCI's National Clinical Trial Network (NCTN) protocols between March 2014 (year 1 of MD Anderson's Lead Academic Participant Site grant) and February 2017. Lastly, from March through August 2018, the Office of Clinical Research Administration underwent a substantive evaluation of all departments and functions, resulting in a revised organizational structure and greater emphasis on integration and accountability across departments to enhance efficiencies within related processes and ensure ongoing performance improvements. The goals of the CPDM are achieved through the following Specific Aims: Aim 1: Clinical Protocol and Data Management: To provide central management and oversight of all aspects of clinical protocol research at MD Anderson. Aim 2: Data and Safety Monitoring: To provide centralized resources for data monitoring, verifying data validity and integrity, and ensuring the safety of study participants in clinical trials. Aim 3: Inclusion of Minorities and Women in Clinical Research: To evaluate, monitor, and enhance the recruitment and retention of women and minorities in MD Anderson clinical research. Aim 4: Inclusion of Children in Clinical Research: To ensure the inclusion of pediatric oncology patients in all MD Anderson clinical trials, except if scientifically and ethically inappropriate.

摘要临床协议和数据管理（CPDM） 临床方案和数据管理（CPDM）的总体目标是提供高质量的基础架构 支持MD Anderson临床方案研究的各个方面。 CPDM的服务，由博士指导 临床研究管理副总监Aman Buzdar包括单一和多人的支持 通过协议寿命进行中心临床试验；人类学科/临床研究教育；审计和 监测主动临床试验；确保IND研究的监管合规性；促进协议财务 管理;并支持生物循环研究。 CPDM补充了协议的活动 通过支持电子协议提交和评估来审查和监视系统（PRMS） 过程。协议系统旧刷新项目（PSLR）于2016年进行了迁移功能 传统系统到一个更现代，稳定的平台。新的电子健康记录（EHR）系统 Oneconnect（EPIC）于2016年3月推出，提供了一个集成的临床，研究和商业平台， 现在有2,188种介入方案和102,134例患者与EHR有关。在过去的六年中，总计 CPDM管理的协议数量已从2012财年的5,018增加到2017财年的5,974（增加 19％）。新的患者注册介入和非介入试验的平均约为35,000 年;但是，在2016财年和2017财年应计（24,676和26,568）的水平上有显着降低。 分别是由于为确保平稳实施连接而做出的努力。重要的是，医学博士 安德森研究人员已将739名患者纳入NCI国家临床试验网络（NCTN）方案 在2014年3月（MD Anderson的主要学术参与者网站赠款的1年）和2017年2月。最后， 从2018年3月到2018年8月，临床研究管理局办公室进行了实质性 评估所有部门和职能 关于各个部门的集成和问责制，以提高相关过程中的效率 确保持续的绩效提高。 CPDM的目标是通过以下特定目的实现的： 目标1：临床方案和数据管理：提供中央管理和监督 MD Anderson的临床协议研究。 目标2：数据和安全监控：为数据监视提供集中资源，验证数据有效性 和完整性，并确保研究参与者在临床试验中的安全。 目的3：将少数民族和妇女纳入临床研究：评估，监控和增强 MD Anderson临床研究中妇女和少数民族的招聘和保留。 目标4：临床研究中纳入儿童：确保将小儿肿瘤学患者纳入所有人 MD Anderson临床试验，除非科学和道德上不适当。