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CLINICAL RESEARCH OFFICE (SHARED RESOURCE)

临床研究办公室（共享资源）

基本信息

批准号：
8740845
负责人：
DAVID HSIANG
金额：
$ 4.47万
依托单位：
UNIVERSITY OF CALIFORNIA-IRVINE
依托单位国家：
美国
项目类别：
财政年份：
1997
资助国家：
美国
起止时间：
1997-09-11 至 2016-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8740845
关键词：
Address Biostatistics Shared Resource Cancer Center Cancer Center Support Grant Case Report Form Clinical Clinical Nurse Specialists Clinical Research Clinical Trials Clinical trial protocol document Communities Community Physician Confidentiality Contracts Data Data Quality Data Set Databases Development Discipline of Nursing Electronics Eligibility Determination Flowcharts Gynecologic Oncology Group Housing Individual Informatics Informed Consent Institutional Review Boards Location Maintenance Modification Monitor National Surgical Adjuvant Breast and Bowel Project Outcome Patients Pharmacologic Substance Pharmacy facility Preparation Principal Investigator Process Protocols documentation Quality Control Regulatory Affairs Reporting Research Research Subjects Resource Sharing Resources Safety Scientist Services Southwest Oncology Group Statistical Data Interpretation System Therapeutic Human Experimentation Therapy Clinical Trials Time Toxic effect University of California Irvine Cancer Center data management improved meetings member migration programs protocol development quality assurance research study

项目摘要

The Clinical Research Office (CRO) coordinates the activities and provides oversight for clinical research studies conducted by Cancer Center Members. Specifically, the objectives of the Shared Resource are to: * Coordinate the clinical research studies initiated by Cancer Center Members through assurance of effective data management, pharmacy support, nursing management, IRB approval, record keeping, implementation, and close-out. * Gather and provide information on protocol availability, eligibility, and accrual. * Prioritize and coordinate, with the appropriate Cancer Center Program Leaders institutional clinical studies of Cancer Center Members, those of cooperative groups (e.g., GOG, SWOG, NSABP) and other studies (e.g., pharmaceutical). * Perform quality control and internal auditing for Cancer Center clinical trials. Internal audits include monitoring 1) compliance with the informed consent process and stated eligibility criteria, 2) appropriate delivery of treatment and implementation of treatment modifications, 3) reporting of clinical outcome and toxicity, and 4) accurate recording of data and 5) maintenance of research subject confidentiality. * Provide assistance to Principal Investigators with clinical research informatics needs for their individual protocols. Services include: Identification of the necessary datasets; development of study-specific case report forms; monitoring of quality of data; and serving a liaison function with the Biostatistics Shared Resource for the purpose of providing data for statistical analysis.

临床研究办公室（CRO）协调活动，并监督癌症中心成员进行的临床研究。具体而言，共享资源的目标是： * 通过确保有效的数据管理、药房支持、护理管理、IRB批准、记录保存、实施和关闭，协调癌症中心成员发起的临床研究。 * 收集并提供有关方案可用性、合格性和应计费用的信息。 * 与适当的癌症中心项目负责人一起，优先考虑和协调癌症中心成员的机构临床研究，合作小组的临床研究（例如，GOG、SWOG、NSABP）和其他研究（例如，制药）。 * 对癌症中心临床试验进行质量控制和内部审核。内部稽查包括监测：1）遵守知情同意程序和规定的合格性标准; 2）适当提供治疗和实施治疗调整; 3）报告临床结局和毒性; 4）准确记录数据; 5）维护研究受试者机密性。 * 协助主要研究者满足其个人方案的临床研究信息学需求。服务包括：确定必要的数据集;制定研究特定病例报告表;监测数据质量;以及与生物统计共享资源进行联络，以便为统计分析提供数据。