Clinical Research Office

临床研究办公室

• 批准号: 8637210
• 负责人: Rafat Abonour
• 金额: $ 8.26万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-22 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8637210
• 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项目。在2006年，