Clinical Research Management Office

临床研究管理办公室

• 批准号: 8302956
• 负责人: Matthew Carabasi
• 金额: $ 17.24万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-06-01 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8302956
• 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.

临床研究管理办公室 临床研究管理办公室（CRMO）是Kimmel癌症中心（KCC）的共享资源。 CRMO与医生、科学家和支持人员合作， Kimmel癌症中心临床试验。CRMO工作人员提供广泛的服务， 研究者及其支持人员的需求。通过这些努力，CRMO已成为 所有与KCC临床试验相关的活动中心。 CRMO的具体目标包括： 促进Kimmel癌症中心内临床试验的发展 协调研究的准备和提交，供CCRC和托马斯审查 杰斐逊大学机构审查委员会 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Kimmel癌症中心临床试验的患者的集中数据库 开发和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（研究生物学，诊断和治疗患者） 恶性疾病）的治疗根据联邦、州和机构法规进行 为临床癌症研究审查委员会提供信息和行政支持 （CCRRC）和KCC数据安全监测委员会（DSMB） 为受资助的试验提供预算编制和财务管理 通过KCC向研究者和公众分发有关正在进行的临床试验的信息 网站 协调多学科工作组会议 对研究者发起的试验进行稽查 Kimmel癌症中心在2006年1月1日至2006年12月31日的时间范围内进行了120多项开放临床研究， 招募999例受试者; 287例入组治疗试验，712例入组非治疗和预防试验。研究者发起 试验（治疗性）患者累积总数为168例，而非治疗性患者累积651例 在2006年1月1日至2006年12月31日的时间范围内，研究者发起了试验，90例患者参加了合作组试验。