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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：
7944562
负责人：
DAVID HSIANG
金额：
$ 8.04万
依托单位：
UNIVERSITY OF CALIFORNIA-IRVINE
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-04-06 至 2012-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7944562
关键词：
Access to Information Accountability Adjuvant Adverse event Biological Biostatistics Shared Resource CCI-779 Calendar Cancer Center Cancer Center Support Grant Case Report Form Chemoprevention Chronic Myeloid Leukemia Clinical Clinical Nursing Clinical Pharmacy Service Clinical Research Clinical Trials Collaborations Communication Computers Confidentiality Consent Coordination and Collaboration Data Data Quality Data Set Development Documentation Drug Industry Electronics Eligibility Determination Ensure Event Foundations Funding Granulocyte-Macrophage Colony-Stimulating Factor Growth Factor Gynecologic Oncology Group Health Personnel Human Resources Imatinib Individual Informatics Informed Consent Infusion procedures International Intervention Laboratories Maintenance Medical Records Modification Monitor National Surgical Adjuvant Breast and Bowel Project Noninfiltrating Intraductal Carcinoma Nurses Nursing Research Operative Surgical Procedures Outcome Pancreatic Adenocarcinoma Participant Pathology Patients Pharmaceutical Preparations Pharmacologic Substance Pharmacy facility Phase Phase I Clinical Trials Physicians Postmenopause Preparation Principal Investigator Procedures Process Protocols documentation Publications Quality Control Radiation Oncology Radiology Specialty Randomized Regulation Regulatory Affairs Reporting Research Ethics Committees Research Personnel Research Subjects Research Support Resectable Resource Sharing Sampling Science Services Shipping Ships Signal Transduction Site Source Southwest Oncology Group Spectrum Analysis Staging Statistical Data Interpretation Surgical Oncology System Time Toxic effect University of California Irvine Cancer Center Visit Woman Work anastrozole compliance behavior data management follow-up inpatient service malignant breast neoplasm member novel oncology programs research study tool

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）协调活动并监督临床研究癌症中心成员进行的研究。具体而言，共享资源的目标是：协调癌症中心成员发起的临床研究，确保有效的数据管理，药房支持，护理管理，IRB批准，记录保存，执行和收尾。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进行优先排序和协调，癌症中心成员的研究，合作团体的研究（例如，GOG、SWOG、NSABP）和其他研究（例如，制药）。对癌症中心的临床试验进行质量控制和内部审计。内部审计包括监测：1）遵守知情同意程序和规定的资格标准，2）适当提供治疗和实施治疗调整，3）报告临床结果，毒性; 4）准确记录数据; 5）维护研究对象的机密性。协助主要研究者满足其个人的临床研究信息学需求协议.服务包括：确定必要的数据集;开发研究特定案例报告表格;监测数据质量;以及与生物统计共享为统计分析提供数据的资源。