CLINICAL TRIALS SUPPORT UNIT

临床试验支持单位

基本信息

批准号：
8181015
负责人：
Martha P. Mims
金额：
$ 17.81万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-17 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8181015
关键词：
AIDS Malignancy Consortium Acquired Immunodeficiency Syndrome Adult Adverse event Ambulatory Care Amendment American Society of Clinical Oncology Area Biostatistics Shared Resource Breast Budgets Cancer Center Cancer Trials Support Unit Cells Child Childhood Clinic Clinical Clinical Cancer Center Clinical Data Clinical Protocols Clinical Research Clinical Sciences Clinical Trials Clinical Trials Database Clinical Trials Unit Clinical trial protocol document Communication Controlled Clinical Trials County Hospitals Credentialing Data Data Base Management Data Collection Data Reporting Databases Date of birth Development Discipline of Nursing Disease Doctor of Medicine Doctor of Philosophy Drug Industry Economically Deprived Population Electronic Mail Enrollment Ensure Ethnic Origin Faculty Feedback Floor Funding Future Gender Gene Transfer General Hospitals HIV Hospitals Human Resources Improve Access Individual Industry Informatics Institution Interview Investigator-Initiated Research Knowledge Leadership Learning Link Lymphoma Maintenance Malignant Neoplasms Medical center Medicine Methodist Church Minority Monitor NCI Center for Cancer Research Names New Agents Newsletter Nurses Nursing Research Online Systems Outpatients Patients Pediatric Hospitals Pediatrics Performance Pharmacologic Substance Pharmacy facility Phase Physicians Population Positioning Attribute Principal Investigator Procedures Process Protocols documentation Quality Control Race Recording of previous events Regulatory Affairs Reporting Research Research Activity Research Ethics Committees Research Infrastructure Research Personnel Research Support Resource Allocation Resources Rest Review Committee Role Scientist Site Solutions Southwest Oncology Group Structure Summary Reports System Texas Therapeutic Clinical Trial Time Training Training Programs Training and Education Uncertainty Underrepresented Minority Update Work Workload arm base cancer cell cancer research center director clinical research site college cost effective experience gene therapy improved innovation institutional biosafety committee malignant breast neoplasm meetings member patient registry programs quality assurance repository response tumor web site

项目摘要

The Clinical Trials Support Unit (CTSU) is a central resource for coordination and reporting on all cancer related clinical research within the College and its affiliated hospitals and ambulatory care centers. The CTSU facilitates liaison with investigators, cooperative groups, federal agencies, and the pharmaceutical industry. In the past 3 years, the CTSU has particularly focused on establishing clinical trials infrastructure for investigators and institutions with less prior experience and knowledge in this area in order to increase clinical trial enrollment to a wide spectrum of cancer-related studies. The CTSU has targeted hospitals and institutions with a higher proportion of minority and economically disadvantaged patients, providing greater access to participation in clinical research for these populations. The CTSU provides overall coordination of and reporting on cancer relevant clinical studies in the DLDCC via 4 major functions: 1) Assistance with regulatory and administrative matters relating to clinical research and trials, including IRB compliance and approval, ongoing amendments and renewal, external agency compliance (such as the FDA), maintenance of regulatory files, 2) Clinical trials informatics expertise especially maintaining an electronic database of cancer related clinical protocols, patient registry and clinical data, and monitoring and reporting on accrual, 3) Quality assurance auditing and personnel training and 4) Research nursing/clinical trials management especially for less experienced investigators or those with limited programs. The CTSU provides efficient, cost-effective support to aid Cancer Center investigators in the conduct of scientifically valuable cancer clinical trials and improves access to these trials, especially for underserved minorities. The main offices of the CTSU are in the Cancer Center administrative offices on the 4th floor of the Cullen Bldg at Baylor College of Medicine with CCGT and Pediatric CTSU offices in the Feigin Center. On site offices for Research Nurses/Coordinators are located in each of the College's major affiliated clinical facilities including the Baylor Clinic, Texas Children's Hospital, the Methodist Hospital (adult component of the CCGT program), the Ben Taub Hospital, and the Michael E. DeBakey VA Medical Center. The Resource Leader is Martha Mims, M.D., Ph.D.

临床试验支持部门 (CTSU) 是协调和报告学院及其附属医院和门诊护理中心内所有癌症相关临床研究的核心资源。 CTSU 促进与调查人员、合作团体、联邦机构和制药行业的联络。在过去 3 年中，CTSU 特别注重为该领域经验和知识较少的研究人员和机构建立临床试验基础设施，以增加广泛的癌症相关研究的临床试验注册人数。 CTSU 已针对医院和少数民族和经济困难患者比例较高的机构，为这些人群提供更多参与临床研究的机会。 CTSU 通过 4 个主要职能提供 DLDCC 中癌症相关临床研究的总体协调和报告： 1) 协助与临床研究和试验相关的监管和行政事务，包括 IRB 合规和批准、持续修订和更新、外部机构合规（例如FDA），维护监管文件，2）临床试验信息学专业知识，特别是维护癌症相关临床方案、患者登记和临床数据的电子数据库，以及应计项目的监测和报告，3）质量保证审核和人员培训和4）研究护理/临床试验管理，特别是针对经验不足或项目有限的研究人员。 CTSU 提供高效、经济高效的支持，帮助癌症中心研究人员开展具有科学价值的癌症临床试验，并改善获得这些试验的机会，特别是对于服务不足的少数群体。 CTSU 的主要办公室位于贝勒医学院卡伦大楼 4 楼的癌症中心行政办公室，CCGT 和儿科 CTSU 办公室位于 Feigin 中心。研究护士/协调员的现场办公室位于学院的每个主要附属临床设施中，包括贝勒诊所、德克萨斯儿童医院、卫理公会医院（成人医院） CCGT 计划）、Ben Taub 医院和 Michael E. DeBakey VA 医疗中心。资源负责人是 Martha Mims，医学博士、哲学博士。