Clinical Research Office

临床研究办公室

• 批准号: 8727154
• 负责人: Rafat Abonour
• 金额: $ 0.71万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8727154
• 关键词: Adult; Ancillary Study; Area; Biometry; Biostatistics Core; Bladder; Bone Marrow Transplantation; Breast; Cancer Center; Cancer Center Support Grant; Chest; Childhood; Clinical; Clinical Investigator; Clinical Oncology; Clinical Research; Clinical Trials; Computers; Conduct Clinical Trials; Consent; Correlative Study; 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; Nurses; Nursing Research; 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; clinical practice; computerized; data management; experience; follow-up; knowledge base; leukemia; melanoma; migration; operation; programs; protocol development; quality assurance; sarcoma; square foot

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。二零零六年， 在IUSCC登记了635名患者的治疗方案，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。 伊利诺伊州立大学西蒙中心CRO是癌症中心所有临床研究人员可用的共享资源。 CRO为癌症临床试验的所有阶段提供中央管理和监督职能，网址为 IUSCC。借助“在线临床肿瘤学研究环境”(OnCore)数据库， 资源提供癌症方案的中央位置、方案特定数据的集中式数据库、列表 当前活动协议的状态报告和协议的状态报告。CRO还管理 每个疾病地点都有可用的试验。此外，作为这一共享资源的一部分，CRO教育和 培训数据经理和护士，并进行审计，以确保最高质量的临床研究 数据。请求协调小组为CRO的以下职能提供支持：培训和监督 研究人员，维护计算机化的数据库以跟踪方案和患者数据，各种质量 保证活动，以及与生物统计核心的互动和数据传输。 总而言之，CRO提供全面的基本服务，使临床研究人员能够 高效地进行试验。这些服务开始于协议开发的早期阶段，并将继续 通过科学评审和研究实施、发表、长期跟踪。这个 生物统计和数据管理共享设施与CRO集成，以确保进行适当的分析 数据管理和促进质量保证监测。