Clinical Protocol and Data Management (CPDM)

项目总结/摘要：临床方案和数据管理 临床研究办公室（OCR）是Norris Cotton癌症中心（NCCC）内的既定办公室 它支持达特茅斯的临床癌症研究。OCR为制药商发起的试验提供支持 (IIT)，合作组试验（作为NCTN牵头学术参与研究中心[LAPS]，NCI ETCTN和全 Alliance、NRG和ECOG-ACRIN成员）和公司申办的研究。OCR是一个服务组织 在NCCC内为研究者提供集中支持和研究数据管理，以及方案 开发、支持监测合作小组研究、筛选潜在研究 参与者，并与联邦和行业赞助商和监管机构联络。OCR提供资源 支持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[CCRC]）、质量改进委员会、临床试验研究指令集 委员会（CTIOSC）和数据安全监测和应计委员会（DSMAC）。OCR已经 积极参与NCI计划，如临床试验报告计划（CTRP）的集中数据表4，以及 监督NCCC作为NCTN LAPS的成功重新应用。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进行新的尝试，因为它 支持上级组织中最大的单一研究小组。在过去四年中， 在达特茅斯的癌症研究试验中招募了1,432名成人受试者和129名儿童受试者; 干预性试验中的受试者和非干预性试验中的687例成人受试者。在这十二个月里， 在本报告期内，共有758例患者参加了NCCC临床试验。其中包括608名患者 在NCCC累积了150例患者，在其他机构开放的NCCC治疗启动的试验中累积了150例患者。的 成人受试者入组包括61%（371）的女性，这一比例高于集水区 女性癌症人群占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，负责监督参与者安全的监测， 研究方案的实施和进展，以及NCCC临床试验数据的有效性和完整性及其 未经另一研究特定安全性和数据监查委员会审查的子研究中心。DSMAC拥有 有权要求对受试者的安全性进行必要的方案修订，暂停研究入组， 研究活动，或向NCCC的CCRC建议关闭研究。对于特定协议，独立内部 监测评估PI和团队资格，以及OCR监管、数据完整性和药房 合规DSMAC和IRB有权立即暂停招募和方案 活动，直至解决与不良事件相关的问题。CCRC和IRB有权 由于对研究受试者或科学完整性的风险达到不可接受的水平而立即关闭研究。CCRC 有权因未能实现应计目标和/或科学进展而关闭研究。

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.