Clinical Research Office

临床研究办公室

• 批准号: 8710483
• 负责人: Rafat Abonour
• 金额: $ 0.54万
• 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 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8710483
• 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.

印第安纳州大学西蒙癌症中心（IUSCC）拥有强大的临床试验计划。在2006年， 635例患者在IUSCC入组治疗方案，并由IUSCC临床研究中心管理 研究办公室（CRO）。此外，969例患者入组相关和辅助研究。 IU Simon Center CRO是癌症中心所有临床研究者的共享资源。 CRO为癌症临床试验的所有阶段提供中央管理和监督职能， IUSCC。借助“在线临床肿瘤学研究环境”（Oncore）数据库， 资源为癌症协议提供了一个中心位置，协议特定数据的集中数据库，列表 当前活动的协议，以及协议的状态报告。合同研究组织还负责管理 每个疾病部位的可用试验。此外，作为这种共享资源的一部分，CRO教育和 培训数据管理人员和护士，并进行审计，以确保最高质量的临床研究 数据要求CCSG为CRO的以下职能提供支持：培训和监督 研究人员，维护计算机化数据库，以跟踪协议和患者数据，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。 总之，CRO提供全面的基本服务，使临床研究者能够 有效地进行审判。这些服务开始于协议开发的早期阶段， 在整个科学审查和研究实施、出版和长期随访中。的 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，并促进质量保证监测。