Clinical Protocol and Data Management

临床方案和数据管理：摘要 临床方案和数据管理(CPDM)功能提供全面的管理和 斯蒂芬森癌症中心(SCC)为临床研究活动提供支持服务。CPDM服务驻留 在SCC的临床试验办公室(CTO)，该办公室由大约200名FTE组成，由 凯瑟琳·摩尔，医学博士(CT)，SCC临床研究副主任。CTO提供集中的 以及为所有SCC成员和临床计划提供的集成研究支持服务，包括全面的 监管支持、数据管理、嵌入疾病现场临床计划的研究协调、 生物信息学、质量保证(审计和数据完整性)、财务、生物样品收购和 协调。对于研究人员发起的试验(IIT)，方案支持单位(PSU)提供全面的 从方案构思到激活、新试验注册和结果报告的支持 临床试验.gov。CTO支持数据安全和监控委员会(DSMC)和书面的DSM计划 (由NCI批准)。此外，它还致力于确保妇女和儿童以及少数群体的审判收益。 而SCC集水区的其他个人在临床研究中历来代表不足。在此期间 在赠款周期内，发起了几项新举措，以加强首席技术官的职能，包括：1)实施 新的CTMS(OnCore)预计将于2022年第三季度完成；2)战略计划的创建和人员配置 项目管理团队；3)创建和配置新的教育和培训团队和新的严重 不良事件(SAE)小组；以及4)扩大质量保证小组和IIT PSU。此外，CTO 为SCC的新细胞疗法计划开发了一个临床研究部分，包括住院患者 研究支持。 2017至2021年间，首席技术官监督了11,121名个人的招聘、管理和报告 在SCC内进行的所有临床研究(3,095项介入治疗，4,216项 不介入治疗，3810人不介入)。在此期间，它促进了524的激活 研究，包括71项机构和外部同行评议的干预研究。这代表着100% 从2017年到2021年，机构间投资信托基金(干预性)增加，应计项目增加40% 2017至2021年间的干预性信息技术。此外，由于有意接触人工智能社区， 在整个赠款周期中，登记参加干预试验的人工智能比例从4.4%增加到6.2%。

CLINICAL PROTOCOL AND DATA MANAGEMENT: ABSTRACT The Clinical Protocol and Data Management (CPDM) function provides comprehensive management and support services for clinical research activities at the Stephenson Cancer Center (SCC). CPDM services reside in the SCC’s Clinical Trials Office (CTO), which is comprised of ~200 FTEs and is under the direction of Kathleen Moore, MD (CT), the SCC Associate Director for Clinical Research. The CTO provides centralized and integrated research support services to all SCC members and clinical programs, including comprehensive regulatory support, data management, research coordination embedded in disease-site clinical programs, bioinformatics, quality assurance (auditing and data integrity), finance, and biospecimen acquisition and coordination. For investigator-initiated trials (IITs), a Protocol Support Unit (PSU) provides comprehensive support from protocol conception to activation, registration of new trials, and results reporting with ClinicalTrials.gov. The CTO supports a Data Safety and Monitoring Committee (DSMC) and written DSM Plan (approved by NCI). In addition, it works to ensure accrual to trials by women and children as well as minorities and other individuals in the SCC catchment area historically underrepresented in clinical research. During this grant cycle, several new initiatives were launched to enhance CTO functions, including: 1) implementation of a new CTMS (OnCore) expected to complete in Q3 2022; 2) creation and staffing of a strategic initiative and project management team; 3) creation and staffing of a new Education and Training team and a new Serious Adverse Event (SAE) team; and 4) expansion of the Quality Assurance team and the IIT PSU. In addition, CTO developed a clinical research component for the SCC’s new cellular therapies program inclusive of inpatient research support. Between 2017 and 2021, the CTO oversaw the recruitment, management and reporting of 11,121 individuals into all clinical research studies being conducted within SCC (3,095 interventional treatment, 4,216 interventional non-treatment, 3,810 non-interventional). During this time it facilitated the activation of 524 studies, including 71 institutional and externally peer-reviewed interventional studies. This represents a 100% increase in IITs (interventional) from 2017 to 2021 and a concomitant 40% increase in accruals to interventional IITs between 2017 and 2021. Further, due to intentional outreach to the AI community the percentage of AI enrolled to interventional trials increased from 4.4% to 6.2% across the grant cycle.