Clinical Research Office

临床研究办公室

• 批准号: 7698897
• 负责人: Rafat Abonour
• 金额: $ 6.81万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7698897
• 关键词: Adult; Ancillary Study; Area; Biometry; Biostatistics Core; Bladder; Bone Marrow Transplantation; Breast; Cancer Center; Cancer Center Support Grant; Category Rating Scale; Chest; Childhood; Clinical; Clinical Investigator; Clinical Oncology; Clinical Research; Clinical Trials; Computers; Conduct Clinical Trials; Consent; Data; Data Analyses; Databases; Developmental Therapeutics Program; Disorder by Site; Effectiveness; Eligibility Determination; Enrollment; Ensure; Environment; Germ Cells; Hematology; Housing; Human Resources; Indiana; Internet; Kidney; Late Effects; Link; Location; Maintenance; Malignant Neoplasms; Maps; Monitor; Monitoring Clinical Trials; Numbers; Nurses; Nursing Research; Operative Surgical Procedures; Outpatients; Patients; Pediatric Hospitals; Pediatrics; Phase; Physicians; Policies; Procedures; Prostate; Protocols documentation; Publications; Regulatory Affairs; Reporting; Research; Research Personnel; Resource Allocation; Resource Sharing; Resources; Review Committee; Services; Solid Neoplasm; Specialist; Staging; Supervision; Supportive care; Team Nursing; Therapeutic; Training; Universities; Women' s Health; cancer site; computerized; data management; experience; follow-up; foot; knowledge base; leukemia; melanoma; migration; programs; protocol development; quality assurance; sarcoma

The Indiana University Simon Cancer Center (IUSCC) has a robust clinical trials program. In the year 2006, 635 patients were enrolled on therapeutic protocols at the IUSCC and managed by the IUSCC Clinical Research Office (CRO). Additionally, there were 969 patients enrolled on correlative and ancillary studies. The IU Simon Center CRO is a shared resource available to all clinical investigators of the Cancer Center. The CRO provides central management and oversight functions for all phases of cancer clinical trials at IUSCC. With the aid of the "On-line Clinical Oncology Research Environment" (Oncore) database, this resource provides a central location for cancer protocols, centralized database of protocol-specific data, list of currently active protocols, and status reports of protocols. The CRO also manages the "mapping" of available trials for each disease site. Moreover, as part of this shared resource, the CRO educates and trains data managers and nurses and it conducts audits to assure the highest quality of clinical research data. Support from the CCSG is requested for the following functions of the CRO: training and supervision of research staff, maintenance of computerized databases to track protocols and patient data, various quality assurance activities, and interaction and data transfer with the Biostatistics Core. In summary, the CRO provides comprehensive essential services that enable the clinical investigator to efficiently conduct trials. These services begin in the early stages of protocol development and continue throughout scientific review and study implementation, publication, and long-term follow-up. The Biostatistics and Data Management shared facility is integrated with the CRO to ensure appropriate analysis of data and to facilitate quality assurance monitoring.

印第安纳大学西蒙癌症中心（IUSCC）有一个强大的临床试验计划。在2006年， 635名患者在IUSCC上招募了治疗方案，并由IUSCC临床管理 研究办公室（CRO）。此外，还有969名患者参加了相关和辅助研究。 IU Simon Center CRO是癌症中心所有临床研究人员的共享资源。 CRO为癌症临床试验的所有阶段提供了中央管理和监督功能 IUSCC。借助“在线临床肿瘤研究环境”（ONCORE）数据库，这 资源提供了癌症协议，协议特定数据的集中数据库的中心位置，列表 当前有效的协议和协议状态报告。 CRO还管理 每个疾病部位的可用试验。此外，作为此共享资源的一部分，CRO教育和 培训数据经理和护士，并进行审核以确保临床研究的最高质量 数据。请求CCSG的支持以进行CRO的以下功能：培训和监督 研究人员，维护计算机数据库以跟踪协议和患者数据，各种质量 保证活动，与生物统计学核心的交互和数据传输。 总而言之，CRO提供了全面的基本服务，使临床研究者能够 有效进行试验。这些服务从协议开发的早期开始，然后继续 在整个科学审查和研究实施，出版和长期随访中。这 生物统计学和数据管理共享设施与CRO集成，以确保适当的分析 数据并促进质量保证监控。