Clinical Protocol and Data Management

摘要-临床方案和数据管理 圣裘德综合癌症中心内的中央礼宾和数据监测办公室 (SJCCC)提供与临床试验相关的集中管理、监管和教育服务 活动。它是协议标准化、法规和合规性指导的协调中心， 行政提交、协议注册数据和监控。CPDMO是临床不可或缺的一部分 试验管理局(CTA)，为进行SJCCC临床试验提供全面的基础设施。 CTA和CPDMO共同履行以下职能，为以下项目提供出色的临床试验支持 SJCCC成员：(1)在标准化框架内促进高质量临床试验的开发； 以满足机构和联邦的要求。(2)维护机构集中报送流程 审查和批准。(3)制定标准，通过监测促进一致的行为和合规 在所有的临床试验中。(4)通过集中临床试验注册确保适当的参与者登记 系统。(5)在附属机构和合作机构提供基础设施和协调试验。(六)坚持 《数据安全监测计划》，国家保监局于2017年8月修订并批准。CPDMO还 为临床试验科学审查委员会提供行政支持，以确保 对SJCCC的所有试验进行科学审查。对研究进行监测与风险程度相称 参与者以及研究的规模和复杂性。SJCCC数据安全监测委员会由 独立监督机构第三阶段试验和高风险试验的外部专家；内部 监督委员会评估个人审计报告的结果和安全趋势，并建议 教育和纠正行动。试验监测和安全报告是所有成员的责任 临床试验过程。特别注意监测由调查员发起的试验，特别是 那些没有外部监测计划的。CPDMO目前有42名工作人员。在海流之上 在筹资期间，新的儿科癌症患者数量增加了11%，从2013财年的459人增加到2013年的516人 2017财年：60%的人参加了介入治疗试验，其中90%的人参加了机构IIT。同样， CPDMO协助5,470人参加了干预性(治疗性和非治疗性)试验，占23% 与上一个供资期间相比，这一类别的应计项目有所增加。此外，我们还协助 30071人参加非干预性临床试验。在本供资期间，CPDMO管理 超过406项前瞻性试验，其中52%是机构IIT。在2017财年，CPDMO的投资组合， 按赞助商细分，包括61%的IIT/同行审查，32%的国家联盟/财团，以及7%的工业。这个 SJCCC支持了36家研究所的30项研究新药申请和新设备豁免。目前， CPDMO支持116个主用多站点IIT。CPDMO致力于通过以下方式为所有SJCCC成员提供服务 支持高效和有效地进行高质量的转化性和临床儿科癌症研究。

ABSTRACT – Clinical Protocol and Data Management The Central Protocol and Data Monitoring Office (CPDMO) within the St. Jude Comprehensive Cancer Center (SJCCC) provides centralized administrative, regulatory, and educational services for clinical trials-related activities. It is the coordinating center for protocol standardization, regulatory and compliance guidance, administrative submissions, protocol registration data, and monitoring. The CPDMO is integral to the Clinical Trials Administration (CTA), which provides comprehensive infrastructure for conducting SJCCC clinical trials. Together, the CTA and CPDMO perform the following functions to provide outstanding clinical trials support to SJCCC members: (1) Facilitate the development of high-quality clinical trials, within a standardized framework, to meet institutional and federal requirements. (2) Maintain a centralized submission process for institutional review and approval. (3) Set standards by fostering consistent conduct and compliance through the monitoring of all clinical trials. (4) Ensure appropriate participant enrollment via a centralized clinical trials registration system. (5) Provide infrastructure and coordinate trials at affiliate and collaborating institutions. (6) Adhere to the Data Safety Monitoring Plan, which was revised and approved by the NCI in August 2017. The CPDMO also provides administrative support to the Clinical Trials Scientific Review Committee to ensure the thorough scientific review of all trials in the SJCCC. Studies are monitored commensurate with the degree of risk to participants and the size and complexity of the study. The SJCCC's Data Safety Monitoring Board is composed of external experts who independently oversee institutional Phase III trials and high-risk trials; an Internal Monitoring Committee assesses findings from individual audit reports and safety trends and recommends educational and corrective actions. Trial monitoring and safety reporting is the responsibility of all members of the clinical trial process. Particular attention is paid to monitoring investigator-initiated trials (IITs), especially those with no external monitoring program. The CPDMO presently includes 42 staff members. Over the current funding period, the number of new pediatric patients with cancer increased 11%, from 459 in FY 2013 to 516 in FY2017: 60% enrolled into interventional therapeutic trials, and 90% of those were in institutional IITs. Similarly, the CPDMO assisted with 5,470 enrollments into interventional (therapeutic and nontherapeutic) trials, a 23% increase in accrual into this category, compared to the previous funding period. In addition, we assisted with 30,071 enrollments into non-interventional clinical trials. During the current funding period, the CPDMO managed more than 406 prospective trials, of which 52% are institutional IITs. During FY2017, the CPDMO's portfolio, subdivided by sponsor, included 61% IIT/peer reviewed, 32% national alliance/consortia, and 7% industrial. The SJCCC supported 30 investigational new drug applications and new device exemptions for 36 IITs. Presently, the CPDMO supports 116 active multisite IITs. The CPDMO is committed to serving all SJCCC members by supporting the efficient and effective conduct of high-quality translational and clinical pediatric cancer research.