Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10456708
• 负责人: ANNE M TRAYNOR
• 金额: $ 28.96万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-04-25 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10456708
• 关键词: Achievement; American; Appointment; Budgets; Businesses; Cancer Center; Cancer Center Support Grant; Clinic; Clinical Data; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Communities; Comprehensive Cancer Center; Conduct Clinical Trials; Consent; Data Management Resources; Data Reporting; Development; Dreams; Ensure; Faculty; Funding; Grant; Health; Health Sciences; Industrialization; Informatics; Infrastructure; Institution; Institutional Review Boards; Intervention; Intervention Trial; Investments; Lead; Leadership; Malignant Childhood Neoplasm; Minority; Mission; Monitor; Multilingualism; NCI Center for Cancer Research; National Comprehensive Cancer Network; Oncology; Outpatients; Patient Care; Patients; Peer Review; Performance; Pharmacologic Substance; Policies; Procedures; Protocols documentation; Quality Control; Regulation; Reporting; Research; Research Activity; Research Personnel; Resource Sharing; Risk; Services; Site; Structure; System; Therapeutic Intervention; Time; Training and Education; Wisconsin; Woman; adjudicate; anticancer research; base; cancer health disparity; cancer therapy; clinical care; clinical infrastructure; data management; data quality; improved; industry partner; innovation; member; outreach; quality assurance; research study

ABSTRACT – CLINICAL PROTOCOL AND DATA MANAGEMENT The Clinical Research Central Office (CRCO) provides the centralized infrastructure for clinical research activities at the UW Carbone Cancer Center (UWCCC). The CRCO includes 87 FTEs who support 244 faculty PIs with an annual operating budget of $6.4M; annual CCSG provides $248K (directs) of the total CRCO budget. Under the leadership of Center Director Dr. Howard Bailey and Associate Director for Clinical Research, Dr. Ruth O’Regan (DT), UWCCC has significantly expanded and centralized the CRCO infrastructure, supported by a $2M investment (non-CCSG) by Dr. Bailey in new annual operating funds. Restructuring has yielded expertise and efficiencies in central administration, study coordination, patient care, regulatory, fiscal, informatics, quality assurance, billing compliance, and educational teams. In 2016, the CRCO supported accrual of 2,582 subjects to 257 research studies across the center. Of the 165 treatment intervention clinical trials in 2016, the sponsor breakdown was as follows: Externally peer reviewed (14 studies, or 8%), Industrial (54, or 33%), Institutional (23, or 14%), and National (74, or 45%). Promising early results of centralization include the reversal in 2016 of a 7-year decline in treatment intervention accrual, improvement in study activation metrics, and reduced CRCO staff turnover. The CRCO supports clinical research conducted on site, through NCTN and ETCTN, through our statewide IIT network Wisconsin Oncology Network (WON), and through our memberships in the Big Ten Cancer Research Consortium (BTCRC) and National Comprehensive Cancer Network (NCCN), with whom we are collaborating and developing new IITs. Research Informatics has expanded, led by a newly hired Assistant Director, Business Analyst, CTMS manager, and a revised OnCore® Support Team, increasing our eCRF development 7-fold. The QA/Compliance team executes our DSMP, enacting risk-based monitoring, determined by study sponsorship and PRMC-adjudicated risk level. Monitoring, auditing, and data quality and assurance reviews include Internal Audits, Compliance Reviews, and Review of SAE reporting. The CRCO has initiated multiple new initiatives to improve our accrual of women and minorities to clinical trials, including wider interactions with the UWCCC Cancer Health Disparities Initiative, increasing support of translator and multi- lingual consenting services, and targeted, multi-culturally appropriate media outreach efforts. The CRCO envisions continued expansion via vigorous support from the UWCCC and industry partnerships, enabling an increasing percentage of our patients’ access to innovative and impactful clinical trials.

摘要 - 临床协议和数据管理 临床研究中央办公室（CRCO）为临床研究提供了集中的基础设施 UW Carbone癌症中心（UWCCC）的活动。 CRCO包括支持244位教职员工的87英尺 PIS年度运营预算为640万美元；年度CCSG提供CRCO总预算的248K $ 248K（指示）。 在中心主任霍华德·贝利（Howard Bailey）博士和临床研究副主任的领导下，博士 UWCCC Ruth O'Regan（DT）已大大扩展并集中了CRCO基础设施，支持 由贝利博士在新的年度运营基金中进行的200万美元投资（非CCSG）。重组已经产生 中央管理，研究协调，患者护理，监管，财政，财政的专业知识和效率 信息信息，质量保证，计费合规性和教育团队。 2016年，CRCO支持赢得的Accral 该中心的257项研究受试者为2,582名受试者。在165次治疗干预临床试验中 2016年，赞助商的细分如下：外部同行评审（14个研究，或8％），工业（54或 33％），机构（23或14％）和国家（74或45％）。有希望的早期集中化结果包括 2016年的逆转治疗干预精度下降了7年，研究激活指标的改善， 并减少了CRCO员工流动。 CRCO支持在现场，NCTN和 ETCTN，通过我们全州IIT网络Wisconsin肿瘤网络（Won），以及通过我们的会员资格 在十大癌症研究联盟（BTCRC）和国家综合癌症网络（NCCN）中 我们正在与我们合作并开发新的IIT。研究信息学已扩大，由新的 雇用助理董事，业务分析师，CTMS经理和修订后的OnCore®支持团队，增加了 我们的ECRF开发7倍。质量保证团队执行我们的DSMP，制定基于风险的监视， 由研究奖学金和PRMC审判的风险水平确定。监视，审计和数据质量以及 保证审查包括内部审计，合规性审查和SAE报告审查。 CRCO有 发起了多项新计划，以改善我们对临床试验的妇女和少数民族的兴趣，包括怀尔德 与UWCCC癌症健康差异倡议的相互作用，越来越多地支持翻译者和多数 语言同意服务，并有针对性的，具有多元文化的媒体外展工作。 crco 设想通过UWCCC和行业伙伴关系的大力支持继续扩展 增加了患者获得创新和有影响力的临床试验的百分比。