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CORE--CLINICAL RESEARCH SERVICES CLINICAL TRIALS OFFICE

核心--临床研究服务临床试验办公室

基本信息

批准号：
7494660
负责人：
SAMUEL JACOBS
金额：
$ 54.09万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
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/7494660
关键词：
African American Amendment Breast Cancer Center Caring Clinical Research Clinical Trials Collaborations Contracts Review Counseling Data Data Collection Data Reporting Databases Development Disorder by Site Doctor of Medicine Doctor of Philosophy Early Diagnosis Ensure Equilibrium Goals Guidelines Head Health system Hospitals Human Resources Investigational Drugs Legal Malignant Neoplasms Manuals Mediation Monitor Numbers Occupational activity of managing finances Operative Surgical Procedures Outpatients Patient Care Patient Recruitments Patients Peer Review Pharmaceutical Services Pharmacologic Substance Positioning Attribute Presbyterian Church Prevention Process Radiation therapy Registered nurse Reporting Research Research Activity Research Ethics Committees Research Infrastructure Research Personnel Resource Sharing Resources Safety Scientific Advances and Accomplishments Serious Adverse Event Services Site Specimen System Therapeutic Therapy Clinical Trials Training Universities University of Pittsburgh Cancer Institute Work cancer education cancer epidemiology day inpatient service medical specialties organizational structure programs research study

项目摘要

The Clinical Research Services (CRS) was established in December 1986 as a shared resource to facilitate development, implementation, and completion of all UPCI clinical research studies. CRS provides study development and implementation assistance, IRB processing, patient recruitment, study coordination, and specimen and data collection for all investigators conducting cancer-related studies at all UPMC Cancer Centers. The University of Pittsburgh Cancer Institute (UPCI) recently reorganized its clinical research organization to be in a better position to rapidly implement clinical trials and to comply with the more stringent regulatory requirements. To achieve these goals, additional infrastructure has been developed, to ensure timely review by the regulatory bodies, review by legal counsel for both UPMC and the University of Pittsburgh, budgetary negotiations with sponsors, and financial review of all aspects of the clinical trial. CRS facilitates IRB review of all clinical research studies approvcd by the PRC, and for which needed resources are allocated. The CRS database maintains up to date on the status of each study, including timely submission of all required documents and amendments to the IRB, study renewal forms, progress reports, Data Safety Monitoring information, Serious Adverse Events, monthly reports, IRB and other correspondences.

临床研究服务部(CRS)成立于1986年12月，是一个共享资源，旨在促进所有UPCI临床研究的开发、实施和完成。CRS为所有UPMC癌症中心进行癌症相关研究的所有研究人员提供研究开发和实施援助、IRB处理、患者招募、研究协调以及样本和数据收集。匹兹堡大学癌症研究所(UPCI)最近重组了其临床研究机构，以便更好地快速实施临床试验，并遵守更严格的监管要求。为了实现这些目标，已经建立了更多的基础设施，以确保监管机构及时审查，由UPMC和匹兹堡大学的法律顾问审查，与赞助商进行预算谈判，以及对临床试验的所有方面进行财务审查。 CRS促进了IRB对中华人民共和国批准的所有临床研究的审查，并为其分配了所需的资源。CRS数据库维护每项研究的最新状态，包括及时提交所有必要的文件和对IRB的修订、研究续展表格、进度报告、数据安全监测信息、严重不良事件、月度报告、IRB和其他通信。