Clinical Trials Shared Resource

临床试验共享资源

基本信息

批准号：
8180834
负责人：
JORDAN D BERLIN
金额：
$ 40.65万
依托单位：
VANDERBILT UNIVERSITY
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：
2010-09-10 至 2015-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8180834
关键词：
Address Adherence Agreement Amendment Annual Reports Area Attention Award Berlin Biopsy Budgets Businesses Cancer Center Cancer Center Support Grant Cancer Therapy Evaluation Program Cancer and Leukemia Group B Case Report Form Clinic Clinical Clinical Data Clinical Oncology Clinical Protocols Clinical Research Clinical Trials Clinical Trials Network Clinical and Translational Science Awards Collaborations Collection Communication Community Clinical Oncology Program Community Hospitals Community Physician Comprehensive Cancer Center Computerized Medical Record Conduct Clinical Trials Consent Consultations Contracts Contracts Review Controlled Study Correlative Study Custom Data Data Collection Databases Development Disease Doctor of Medicine Eastern Cooperative Oncology Group Effectiveness Electronics Elements Eligibility Determination Enrollment Ensure Environment Fees Funding Future Goals Grant Growth Healthcare Hematology Hospitals Human Resources Institutes Institution Jordan Journals Knowledge Leadership Left Letters Location Malignant Neoplasms Mediation Medical Mission Modality Monitor Movement New Agents Nurses Nursing Research Occupational activity of managing finances Oncologist Online Systems Oregon Outpatients Patients Peer Review Grants Pharmacologic Substance Phase Physician Executives Physicians Preparation Principal Investigator Procedures Process Protocols documentation Publishing Quality Control Recommendation Registered nurse Reporting Research Research Activity Research Contracts Research Ethics Committees Research Personnel Research Support Resolution Resource Allocation Resource Sharing Resources Review Committee Safety Schools Scientist Screening procedure Secure Services Shipping Ships Site Site Visit Source Specimen Specimen Handling Standardization Structure System Testing The Vanderbilt-Ingram Cancer Center at the Vanderbilt University Time Time Management Training Training and Education United States Universities Update Visit Work Writing base cost cost effective data management design experience follow-up implementation trial improved informatics shared resource meetings member novel oncology operation organizational structure patient population protocol development response sample collection skills sound statistics symposium systems research tool tumor web site

项目摘要

The Clinical Trials Shared Resource (CTSR) facilitates and enhances the efficiency of clinical trial conduct among the many elements of the VICC. The CTSR brings together critical human resources that help ensure standardization of training of all key research personnel including physicians, research nurses, data management and regulatory staff. The major areas of responsibility of the CTSR include support for all of the regulatory requirements such as IRB submissions and annual reporting, IND submissions and annual reporting, as well as assistance with protocol submissions to the Scientific Review Committee, the GCRC and the NCI. In addition, the CTSR provides assistance with budget development, contract negotiations, and resolution of problems pertaining to resource allocations. The CTSR also provides data management for all clinical trials and research nursing support as required by the clinical protocol. The primary mission of the CTSR is to assist VICC investigators in developing, activating and completing scientifically meritorious clinical trials in an efficient, cost-effective and technically sound manner. Dr. Jordan Berlin is the Medical Director of the CTSR. He is assisted by Debra Adamson, M.S., the Executive Director, who is responsible for the day-to-day operations of the CTSR. A multitude of other staff provides support for the widely varying functions of this Shared Resource.

临床试验共享资源 (CTSR) 促进并提高了 VICC 众多要素中临床试验实施的效率。 CTSR 汇集了关键的人力资源，有助于确保所有关键研究人员（包括医生、研究护士、数据管理和监管人员）的培训标准化。 CTSR 的主要职责领域包括支持所有监管要求，例如 IRB 提交和年度报告、IND 提交和年度报告，以及协助向科学审查委员会、GCRC 和 NCI 提交方案。此外，CTSR 还为预算制定、合同谈判和解决与资源分配相关的问题提供帮助。 CTSR 还根据临床方案的要求为所有临床试验和研究护理支持提供数据管理。 CTSR 的主要使命是协助 VICC 研究人员以高效、具有成本效益且技术可靠的方式开发、启动和完成具有科学价值的临床试验。 Jordan Berlin 博士是 CTSR 的医疗主任。他由执行董事黛布拉·亚当森 (Debra Adamson, M.S.) 协助，后者负责 CTSR 的日常运营。许多其他工作人员为该共享资源的各种不同功能提供支持。