OFFICE OF CLINICAL RESEARCH

临床研究办公室

• 批准号: 8015011
• 负责人: JAMES M PIPAS
• 金额: $ 21.28万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 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/8015011
• 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; 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; operation; 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）协调药物的审查、启动、实施和安全监测