Clinical Research Management Office

临床研究管理办公室

• 批准号: 8378895
• 负责人: Matthew Carabasi
• 金额: $ 16.81万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8378895
• 关键词: Awareness; Biology; Budgets; Cancer Center; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Conduct Clinical Trials; Data; Databases; Development; Diagnosis; Disease; Ensure; Funding; General Population; Group Meetings; Institutional Review Boards; Malignant - descriptor; Malignant Neoplasms; Mission; Office Management; Patients; Physicians; Preparation; Prevention; Regulation; Research Personnel; Resource Sharing; Resources; Review Committee; Scientist; Services; Therapeutic; Therapy Clinical Trials; Time; Translational Research; Universities; Update; abstracting; anticancer research; multidisciplinary; oncology; programs; quality assurance; web site; working group

CLINICAL RESEARCH MANAGEMENT OFFICE The Clinical Research Management Office (CRMO) is a shared resource of the Kimmel Cancer Center (KCC). The CRMO collaborates with physicians, scientists and support staff in the development and implementation of Kimmel Cancer Center clinical trials. The CRMO staff provides a broad range of services tailored to the specific needs of the investigator and his/her support staff. Through these efforts the CRMO has established itself as the center of all activities related to KCC clinical trials. Specific aims of the CRMO include: ¿ Facilitate the development of clinical trials within the Kimmel Cancer Center ¿ Coordinate the preparation and submission of studies for review by the CCRC and the Thomas Jefferson University Institutional Review Board ¿ Collect, abstract, maintain and update data specific to patients entered into clinical trials ¿ Maintain a centralized data base of patients participating in Kimmel Cancer Center clinical trials ¿ develop and maintain an ongoing quality assurance program that will ensure the accuracy of data ¿ ensure that oncology clinical trials (studying the biology, diagnosis and treatment of patients with malignant disease) are conducted according to federal, state and institutional regulations ¿ provide information and administrative support to the Clinical Cancer Research Review Committee (CCRRC) and the KCC Data Safety Monitoring Board (DSMB) ¿ provide budget development and fiscal management of funded trials ¿ distribute information on active clinical trials to investigators and the general public through the KCC website ¿ Coordinate Multidisciplinary Working Group meetings ¿ Auditing of Investigator Initiated Trials The Kimmel Cancer Center had over 120 open clinical studies in the 1/1/06-12/31/06 time frame with a total accrual of 999 subjects; 287 to therapeutic and 712 to non-therapeutic and prevention trials. Investigator-initiated trials (therapeutic) patient accrual total was 168 while there were 651 patients accrued to non therapeutic investigator initiated trials and 90 patients accrued to cooperative group trials in the 1/1/06-12/31/06 time frame.

临床研究管理处 临床研究管理办公室(CRMO)是金梅尔癌症中心(KCC)的共享资源。 CRMO与医生、科学家和支持人员合作，制定和实施 坎摩尔癌症中心的临床试验。CRMO工作人员根据具体情况提供广泛的服务 调查员及其支助人员的需求。通过这些努力，CRMO已经确立了自己作为 与KCC临床试验相关的所有活动中心。 CRMO的具体目标包括： ？促进在基梅尔癌症中心内开展临床试验 协调编写和提交研究报告，供CCRC和Thomas审查 杰斐逊大学院校评审委员会 ？收集、提取、维护和更新进入临床试验的患者的特定数据 ？维护参与基梅尔癌症中心临床试验的患者的集中数据库 ？制定并维护持续的质量保证计划，以确保数据的准确性 确保肿瘤学临床试验(研究癌症患者的生物学、诊断和治疗 恶性疾病)是根据联邦、州和机构的规定进行的 ？向临床癌症研究审查委员会提供信息和行政支持 (CCRRC)和KCC数据安全监控委员会(DSMB) ？为资助的试验提供预算编制和财务管理 ？通过KCC向研究人员和公众分发正在进行的临床试验的信息 网站 协调多学科工作组会议 ？对调查员发起的试验的审计 在1/1/06-12/31/06的时间范围内，Kimmel癌症中心有120多项开放的临床研究，总共 999名受试者；287名治疗性试验和712名非治疗性和预防性试验。由调查人员发起 试验(治疗性)患者总数为168人，而非治疗性患者为651人 研究人员启动了试验，在1/1/06-12/31/06时间范围内，90名患者参加了合作小组试验。