Clinical Protocol and Data Management

摘要-临床方案和数据管理 临床研究中心办公室（CRCO）为临床研究提供集中的基础设施 UW Carbone癌症中心（UWCCC）CRCO包括87名全职员工，支持244名教师 PI的年度运营预算为640万美元; CCSG每年提供CRCO总预算中的24.8万美元（直接）。 在中心主任霍华德贝利博士和临床研究副主任的领导下， Ruth O 'Regan（DT），UWCCC显著扩展并集中了CRCO基础设施， 贝利博士在新的年度运营基金中投资200万美元（非CCSG）。重组产生了 中心管理、研究协调、患者护理、监管、财政 信息学、质量保证、计费合规和教育团队。2016年，CRCO支持权责发生制 2,582名受试者参加了该中心的257项研究。在165项治疗干预临床试验中， 2016年，申办者细分如下：外部同行评审（14项研究，或8%），工业（54项，或 33%），机构（23，或14%）和国家（74，或45%）。集中化的早期成果包括： 2016年逆转了7年来治疗干预累积下降的趋势，研究激活指标改善， 减少了CRCO的员工流动率。CRCO通过NCTN支持现场进行的临床研究， ETCTN，通过我们的全州IIT网络威斯康星州肿瘤网络（WON），并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， 我们正在与他们合作并开发新的IIT。研究信息学已经扩大，由一个新的 聘请了助理总监、业务分析师、CTMS经理和经过修订的OnCore®支持团队， 我们的eCRF开发7倍。QA/合规团队执行我们的DSMP，实施基于风险的监控， 由研究申办方和PRMC裁定的风险水平确定。监测、审计和数据质量， 保证审查包括内部审计、合规审查和SAE报告审查。CRCO已 启动了多项新举措，以提高女性和少数族裔参与临床试验的比例，包括更广泛的 与UWCCC癌症健康差异倡议的互动，增加翻译和多媒体的支持， 语言同意服务，以及有针对性的、适合多种文化的媒体外联工作。CRCO 设想通过UWCCC和行业合作伙伴的大力支持继续扩展， 提高我们的患者获得创新和有影响力的临床试验的比例。

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.