OFFICE OF CLINICAL RESEARCH

临床研究办公室

• 批准号: 7944680
• 负责人: JAMES M PIPAS
• 金额: $ 19.98万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-21 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7944680
• 关键词: Address; Adherence; Adverse event; Agreement; Award; Breast; Budgets; Calendar; Cancer Center; Cancer Center Support Grant; Case Report Form; Clinical; Clinical Oncology; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Database; Collaborations; Conduct Clinical Trials; Consent; Consent Forms; Contracts; Data; Data Collection; Databases; Development; Disease; Disorder by Site; Documentation; Education; Eligibility Determination; Enrollment; Ensure; Evaluation; Funding; Gossypium; Grant; Gynecologic Oncology; Head and neck structure; Health system; Housing; Informed Consent; Intervention Trial; Investigational Drugs; Lung; Maintenance; Medical center; Monitor; Monitoring Clinical Trials; New England; Nursing Research; Oncology Group; Operative Surgical Procedures; Patients; Peer Review; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Physician Executives; Policies; Positioning Attribute; Principal Investigator; Prostate; Protocol Compliance; Protocols documentation; Records; Recruitment Activity; Regulation; Reporting; Research; Research Contracts; Research Ethics Committees; Research Personnel; Research Support; Resources; Rural Hospitals; Safety; Screening procedure; Services; Site; Specialist; Standardization; Supervision; System; Technology; Therapy Clinical Trials; Training; Training Support; Update; Work; Writing; anticancer research; base; computerized; data management; follow-up; human subject; leukemia/lymphoma; medical schools; meetings; melanoma; member; programs; protocol development; quality assurance; tumor registry; working group

The Office of Clinical Research (OCR) coordinates the review, initiation, conduct, and safety monitoring of clinical trials at the Morris Cotton Cancer Center. The OCR now functions as a branch of the Clinical Trials Office (CTO) of Dartmouth Medical School. The OCR has recently undergone a dramatic expansion in order to better accommodate clinical research needs within the Cancer Center. Components of the OCR are (1) Administrative staff, including the Medical Director, the Administrative Director, the Regulatory Compliance Officer, and the Clinical Operations Coordinator; (2) Research Support staff¿a research pharmacist, a pharmacy technician, six research RNs, and 24 clinical research assistants/coordinators; (3) interface with the Protocol Review and Monitoring System, consisting of the Clinical Cancer Research Committee (CCRC) and the Safety and Data Monitoring Committee (SDMC); (4) the institutionally funded Dartmouth-Hitchcock Tumor Registry, staffed by three registrars; and (5) a Clinical Trials Management System (Velos eResearch). The OCR maintains local Dartmouth Medical School investigator-initiated studies, Dartmouth investigatorinitiated studies relying on a consortia of working group enrolling sites, cooperative group protocols, and industrial trials. It is responsible for assisting in formatting protocols, writing consent forms, maintaining Institutional Review Board (CPHS) and SDMC records, developing budgets, assessing impact on institutional resources, activating protocols, assessing eligibility, developing data collection forms and clinical trials databases, and collecting and managing data. A commitment to research and clinical trial enrollment support has been integrated into the current expansion of the Dartmouth-Hitchcock Medical Center into a regional network of clinical facilities. Prioritization of clinical trials is determined within the 11 NCCC Clinical Oncology Groups, with approval by the CCRC. The OCR acts as a checkpoint prior to activation of protocols to ensure that all appropriate administrative aspects of trials are complete. Chargeback policies of the OCR accurately reflect usage and are based on patient accrual to reviewed and approved protocols. For the CCSG fiscal year ending November 30, 2007, the OCR supported 215 active trials. These trials represented service to 32 different Pis. Support of these studies during this period included the new registration of 484 patients and follow-up for 1,876 patients previously enrolled. For the most recent reporting period for our tumor registry in 2006, we entered 487 of 2,582 (1990) patients on therapeutic trials. Throughout this award period, approximately 40% of patients entered onto intervention trials were accrued to institutional trials.

临床研究办公室（OCR）负责协调以下项目的审查、启动、实施和安全性监测： 莫里斯科顿癌症中心的临床试验。OCR现在作为临床试验的分支发挥作用 达特茅斯医学院办公室（CTO）。OCR最近经历了戏剧性的扩张， 以更好地满足癌症中心的临床研究需求。OCR的组成部分是（1） 行政人员，包括医学总监、行政总监、法规合规部 （2）研究支持人员：一名研究药剂师，一名 药房技术员，6名研究RN和24名临床研究助理/协调员;（3）与 由临床癌症研究委员会（CCRC）组成的方案审查和监测系统 和安全和数据监测委员会（SDMC）;（4）机构资助的达特茅斯-希区柯克 肿瘤登记处，由三名登记员组成;和（5）临床试验管理系统（Velos eResearch）。 OCR维护着当地达特茅斯医学院发起的研究，达特茅斯医学院发起的研究 依赖于工作组招募研究中心联盟、合作组协议和 工业试验。它负责协助格式化协议，撰写同意书，维护 机构审查委员会（CPHS）和SDMC记录、制定预算、评估影响 机构资源，激活方案，评估资格，制定数据收集表和临床 试验数据库，收集和管理数据。对研究和临床试验入组的承诺 支持已被纳入目前的达特茅斯-希区柯克医疗中心的扩建，成为一个 区域临床设施网络。临床试验的优先顺序由11个NCCC临床中心确定 肿瘤组，经CCRC批准。OCR在激活协议之前充当检查点 确保完成审判的所有适当行政工作。OCR的按存储容量使用计费政策 准确反映使用情况，并基于患者对已审查和批准方案的累积。为 截至2007年11月30日的CCSG财政年度，OCR支持了215项有效试验。这些试验代表了 服务于32个不同的私家侦探在此期间，对这些研究的支持包括新注册的484项研究。 患者，并对之前入组的1，876例患者进行随访。在我们最近的报告期内， 在2006年的肿瘤登记中，我们进入了2,582（1990）例患者中的487例进行治疗试验。在整个颁奖过程中 在此期间，大约40%进入干预试验的患者进入了机构试验。