Children's Oncology Group Statistics and Data Center

描述（由申请人提供）：儿童肿瘤学组（COG）统计和数据中心（SDC）与COG成员合作，设计，分析和报告儿童癌症治疗的临床试验结果，以及这些恶性肿瘤生物学的相关实验室伴随研究。具体而言，COG SDC人员：参与COG研究优先事项的设定和评估;合作开发研究概念和方案。特别是，SDC的成员制定研究的统计考虑因素;合作开发和实施本集团临床数据管理系统的研究病例报告表;监测研究入组以及研究数据提交的质量和完整性;为研究组成员和方案编制关于研究实施和不良事件经历的中期报告-为集团的数据和安全监测委员会指定研究结果的中期分析;为集团成员编制研究结果的最终报告;与实验室合作，将标本数据和高维基因组学数据与COG临床和结果数据联系起来，并对这些数据进行分析以供发表;制作技术报告，详细分析集团的摘要和手稿;进行数据库和方法研究的相关集团的研究;执行CDUS和结果报告;监测COG成员机构的表现，为集团的机构绩效监测委员会制作报告;根据集团的政策和程序，向SDC外部的调查人员提供来自COG研究的数据;酌情参与国家临床试验网络倡议和CTEP委员会。

DESCRIPTION (provided by applicant): The Children's Oncology Group (COG) Statistics and Data Center (SDC), collaborates with the COG membership to design, conduct analyze and report the results of clinical trials of the treatment of childhood cancers and associated, laboratory-based, companion studies of the biology of these malignancies. Specifically, COG SDC personnel: Participate in the setting and evaluation of COG research priorities; collaborate in the development of study concepts and protocols. In particular, members of the SDC develop the study's statistical considerations; collaborate in the development and implementation of the study's case- report forms for the Group's clinical data management system; monitor study enrollment and the quality and completeness of study data submission; produce interim reports on study conduct and adverse event experience for the Group membership and protocol-specified interim analyses of study outcomes for the Group's Data and Safety Monitoring Committees; produce final reports of the study results for the Group membership; collaborate with laboratories to link specimen data and high dimensional genomics data with COG clinical and outcome data and to produce analyses of these data for publication; produce Technical Reports, detailing analyses performed for Group abstracts and manuscripts; conduct database and methodological research of relevance to the Group's research; perform CDUS and results reporting; monitor the performance of COG member institutions, producing reports for the Group's Institutional Performance monitoring Committee; provide data derived from COG studies to investigators external to the SDC in accordance with the policies and procedures of the Group; participate in National Clinical Trials Network initiatives and CTEP committees as appropriate.