CLINICAL TRIALS SUPPORT UNIT

临床试验支持单位

• 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
• 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

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的所有相关临床研究的中心资源。 CTSU促进了与研究人员，合作团体，联邦机构和制药行业的联络。在过去的三年中，CTSU特别专注于为研究人员和机构建立临床试验基础设施，在该领域的经验和知识较少，以便将临床试验的入学率提高到广泛的癌症相关研究。 CTSU针对医院和 比例较高的少数族裔和经济不利的患者的机构为这些人群的临床研究提供了更多的机会。 CTSU通过4个主要功能提供了DLDCC中有关癌症相关临床研究的总体协调和报告：1）与临床研究和试验有关的监管和行政事务的帮助，包括IRB的合规性和批准，持续的修正案和持续的修正案和更新，外部代理机构合规性，尤其是FDA的临床临床范围，临床范围的临床范围，2），2）临床方案，患者注册表和临床数据以及应计监控和报告，3）质量保证审计和人员培训以及4） 研究护理/临床试验管理，特别是对于经验不足的研究人员或计划有限的研究人员。 CTSU提供有效，具有成本效益的支持，以帮助癌症中心的研究人员进行科学有价值的癌症临床试验，并改善对这些试验的访问，尤其是对于服务不足的少数民族。 CTSU的主要办公室位于贝勒医学院Cullen Bldg 4楼的癌症中心行政办公室，在费金中心（Feigin Center）设有CCGT和儿科CTSU办事处。 在研究护士/协调员的现场办事处都位于该学院的每个主要关联临床设施中 CCGT计划），Ben Taub医院和Michael E. Debakey VA医疗中心。 资源负责人是玛莎·米姆斯（Martha Mims），医学博士，博士学位。