Clinical Protocol and Data Management (CPDM)

项目摘要/摘要：临床方案和数据管理 临床研究办公室(OCR)是诺里斯棉花癌症中心(NCCC)内设立的办公室。 支持达特茅斯大学的癌症临床研究。OCR为研究人员发起的试验提供支持 (IIT)、合作小组试验(作为NCTN领先的学术参与站点[LAPS]、NCI ETCTN和Full 联盟成员、NRG和ECOG-ACRIN)，以及企业赞助的研究。OCR是一个服务组 在NCCC内为研究人员提供集中支持和研究数据管理，以及协议 开发、支持对合作小组研究的监测、筛选潜在研究 参与者，以及与联邦和行业赞助商和监管机构的联系。OCR提供资源 对NCCC临床方案科学审查委员会(当地称为临床癌症审查委员会)的支持 委员会[CCRC])、质量改进委员会、临床试验调查命令集 委员会(CTIOSC)和数据安全监测和积累委员会(DSMAC)。OCR已经被 积极参与NCI计划，如临床试验报告计划(CTRP)的集中数据表4 监督NCCC作为NCTN圈的成功再应用。OCR的跟踪记录为 在达特茅斯-希区柯克卫生系统内为研究企业试行新的努力，因为它 支持上级组织中最大的单个研究小组。在过去的四年里，总共有2392 达特茅斯大学的成年受试者和129名儿科受试者参加了癌症研究试验；1432名成年人 干预性试验受试者，非干预性试验成年受试者687人。在过去的12个月里 在报告所述期间，共有758名患者参加了NCCC临床试验。这包括608名患者 在NCCC积累了150名患者，在其他机构开始了由NCCC调查员发起的试验。这个 成人科目的入学人数包括61%(371名)的女性，这一百分比高于集水区 女性癌症人口占53%(11,984名癌症患者中有6,326名女性)。关于数据安全， DSMAC是一个特许的多学科委员会，负责监督参与者的安全， 研究方案的实施和进展，以及NCCC和ITS临床试验数据的有效性和完整性 未经另一项研究特定的安全和数据监测委员会审查的子网站。DSMAC拥有 有权要求为参与者的安全进行必要的方案修改，暂停研究登记，以及 研究活动，或向NCCC的CCRC建议关闭研究。对于特定协议，独立的内部 监控评估PI和团队资质，以及OCR法规、数据完整性和药房 合规性。DSMAC和IRB有权立即暂停应计费用和协议 活动，直到与不良事件相关的关切得到解决。CCRC和IRB有权 由于研究对象的风险或科学完整性达到不可接受的水平，应立即关闭研究。中国中车 有权因未能实现应计目标和/或科学进步而关闭研究。

Project Summary/Abstract: Clinical Protocol and Data Management The Office of Clinical Research (OCR) is the established office within the Norris Cotton Cancer Center (NCCC) which supports clinical cancer research at Dartmouth. The OCR provides support for investigator-initiated trials (IIT), cooperative group trials (as an NCTN Lead Academic Participating Site [LAPS], NCI ETCTN, and Full Member of Alliance, NRG, and ECOG-ACRIN), and corporate-sponsored studies. The OCR is a service group within NCCC to provide investigators centralized support and study data management, as well as protocol development, support for monitoring for cooperative group studies, screening for potential research participants, and liaison with federal and industry sponsors and regulatory bodies. The OCR provides resource support to the NCCC clinical protocol scientific review committee (known locally as the Clinical Cancer Review Committee [CCRC]), the Quality Improvement Committee, the Clinical Trial Investigational Order Set Committee (CTIOSC), and the Data Safety Monitoring and Accrual Committee (DSMAC). The OCR has been active in NCI initiatives, such as the Clinical Trial Reporting Program’s (CTRP) centralized data table 4, as well as overseeing the successful re-application of NCCC as an NCTN LAPS. The OCR has a track record of piloting new endeavors for the research enterprise within the Dartmouth-Hitchcock Health system, as it supports the largest single research group in the parent organization. Over the last four years a total of 2,392 adult subjects and 129 pediatric subjects were enrolled in cancer research trials at Dartmouth; 1,432 adult subjects in interventional trials, and 687 adult subjects in non-interventional trials. During the twelve-month reporting period, a total of 758 patients were accrued to NCCC clinical trials. This includes 608 patients accrued at NCCC and 150 patients accrued to NCCC investigator-initiated trials open at other institutions. The adult subject enrollment included 61% (371) women, which percentage-wise is higher than the catchment area female cancer population of 53% (female n=6,326 out of 11,984 cancer patients). With regard to data safety, DSMAC is a chartered multidisciplinary committee charged with overseeing monitoring of participant safety, conduct and progress of research protocols, and the validity and integrity of clinical trials data at NCCC and its subsites that are not reviewed by another study-specific safety and data monitoring committee. DSMAC has the authority to require protocol amendments required for participants’ safety, suspend study enrollment and study activities, or recommend study closure to NCCC’s CCRC. For specific protocols, independent internal monitoring assesses PI and team qualifications, as well as OCR regulatory, data integrity, and pharmacy compliance. The DSMAC and the IRB have the authority to suspend immediately accrual and protocol activities until concerns related to the adverse events are addressed. CCRC and the IRB have the authority to close a study immediately due to an unacceptable level of risk to study subjects or scientific integrity. CCRC has authority to close studies due to failure to achieve accrual goals and/or scientific progress.