权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Clinical Research

临床研究

基本信息

批准号：
7332204
负责人：
RAYMOND P PEREZ
金额：
$ 20.54万
依托单位：
DARTMOUTH COLLEGE
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/7332204
关键词：
Antineoplastic Protocols Back Breast Budgets Cancer Center Cancer Center Support Grant Cancer Patient Caring Charge Chemoprevention Chest Clinic Clinical Clinical Investigator Clinical Oncology Clinical Research Clinical Research Protocols Clinical Trials Clinical Trials Data Monitoring Committees Clinical Trials[{..}] Cancer Treatment Consent Forms Data Data Collection Databases Detection Diagnosis Diagnostic radiologic examination Discipline Discipline of Nursing Disorder by Site Doctor of Medicine Eligibility Determination Ensure Funding Genitourinary system Gynecologic Oncology Hematology Hospitals Individual Laboratories Leadership Malignant Neoplasms Medical Faculty Medical Oncology Monitor Monitoring Clinical Trials Newly Diagnosed Norris Cotton Cancer Center Nursing Faculty Oncology Group Operative Surgical Procedures Palliative Care Palliative Care Nursing Pathology Patient Care Patients Pediatric Oncology Peer Review Pharmacists Pharmacy facility Physicians Policies Process Protocols documentation Radiation Oncology Records Registered nurse Registries Reporting Research Research Ethics Committees Research Support Resource Sharing Resources Safety Screening procedure Services Site Staging Standards of Weights and Measures Surgical Oncology System Translational Research Work Writing anticancer research base cancer care cancer research center director cancer site cooperative study gastrointestinal medical schools melanoma member multidisciplinary neuro-oncology oncology patient oriented research professor programs tumor

项目摘要

The Clinical Research Office Shared Resource (CRO) oversees the review, initiation, conduct, and safety monitoring of clinical trials at the Norris Cotton Cancer Center. The CRO components are 1) an administrative staff including the Shared Resource Director, an Associate Director, an Assistant Director, a financial manager, and a protocol assistant; 2) the Protocol-Specific Research Support staff, comprising a research pharmacist, a pharmacy technician, two research registered nurses, and 16 clinical research assistants / coordinators; 3) the Protocol Review and Monitoring System, consisting of the Clinical Cancer Research Committee (CCRC) and the Safety and Data Monitoring Committee (SDMC); and 4) the Dartmouth-Hitchcock Tumor Registry, staffed by three registrars. Although DHMC and the NCCC have designated the CRO as the office responsible for administrative oversight of all aspects of clinical cancer research including the hospital tumor registry, our request for CCSG funding is for the more narrowly defined functions of this Shared Resource related to support peer-reviewed clinical trials of cancer treatment and chemoprevention. The CRO maintains local Dartmouth Medical School studies, working group studies, cooperative group protocols, and industrial trials. It is responsible for assisting in formatting protocols, writing consent forms, maintaining Institutional Review Board and SDMC records, developing budgets, assessing impact on institutional resources, activating protocols, assessing eligibility, developing data collection forms and databases, and collecting and managing data. Prioritization of clinical trials is determined within the 12 NCCC Clinical Oncology Groups, with approval by the CCRC. The CRO acts as a checkpoint prior to activation of protocols to ensure that all appropriate administrative aspects of trials are complete. Charge-back policies of the CRO accurately reflect usage, and are based on patient accrual to reviewed and approved protocols.

临床研究办公室共享资源 (CRO) 负责监督 Norris Cotton 癌症中心临床试验的审查、启动、实施和安全监测。 CRO 的组成部分包括： 1) 行政人员，包括共享资源总监、副总监、助理总监、财务经理和礼宾助理； 2) 方案特定研究支持人员，包括一名研究药剂师、一名药房技术员、两名研究注册护士和 16 名临床研究助理/协调员； 3）方案审查和监测系统，由临床癌症研究委员会（CCRC）和安全与数据监测委员会（SDMC）组成； 4) 达特茅斯-希区柯克肿瘤登记处，由三名登记员组成。尽管 DHMC 和 NCCC 已指定 CRO 为办公室，负责对临床癌症研究的各个方面（包括医院肿瘤登记处）进行行政监督，但我们对 CCSG 资金的请求是针对更狭隘的领域。该共享资源的定义功能与支持癌症治疗和化学预防的同行评审临床试验有关。 CRO 维护当地达特茅斯医学院的研究、工作组研究、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和 SDMC 记录、制定预算、评估对机构资源的影响、激活协议、评估资格、制定数据收集表格和数据库，以及收集和管理数据。临床试验的优先顺序由 12 个 NCCC 临床肿瘤学小组确定，并经 CCRC 批准。 CRO 充当协议激活之前的检查点，以确保试验的所有适当管理方面均已完成。 CRO 的退款政策准确反映了使用情况，并基于患者对经审查和批准的方案的应计情况。