Protocol Review and Monitoring System

方案审查和监控系统

基本信息

批准号：
8180661
负责人：
MELANIE E ROYCE
金额：
$ 6.22万
依托单位：
UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-01 至 2015-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8180661
关键词：
Accountability Addendum Address Adverse event Algorithms Amendment Back Be++ element Beryllium Biotechnology Cancer Biology Cancer Center Cancer Control Cancer Patient Cancer Research Project Chairperson Childhood Client Clinic Clinical Clinical Cancer Center Clinical Nursing Clinical Nursing Research Clinical Oncology Clinical Protocols Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Clinical assessments Committee Members Committee Membership Communication Communities Conceptions Conflict of Interest Constitution Data Doctor of Philosophy Documentation Drug Industry Eligibility Determination Enrollment Ensure Ethical Review Ethics Evaluation Faculty Future Genitourinary system Goals Group Meetings Growth Guidelines Gynecologic Oncology Head and neck structure Hematologic Neoplasms Housing Human Industry Intervention Leadership Left Logistics Malignant Female Reproductive System Neoplasm Malignant Neoplasms Malignant neoplasm of esophagus Malignant neoplasm of gastrointestinal tract Malignant neoplasm of lung Medical Medical Oncologist Medical Oncology Medical center Minor Monitor Names New Mexico Nursing Research Office Nursing Oncologist Orthopedics Outcome Paper Pathology Patients Pediatric Hematology/Oncology Pediatric Oncology Performance Persons Pharmaceutical Preparations Pharmacists Pharmacologic Substance Pharmacy facility Phase Physician Executives Physicians Policies Prevention Prevention Research Principal Investigator Procedures Process Progress Reports Protocols documentation Publications Published Comment Radiation Oncology Radiology Specialty Randomized Recommendation Recruitment Activity Regulatory Affairs Reporting Research Research Design Research Ethics Committees Research Personnel Research Subjects Research Support Resources Rest Review Committee Risk Safety Scientist Screening procedure Site Site Visit Source Specialist Specific qualifier value Structure Supervision Supportive care Surgical Oncology System Testing Time Training Translational Research Translations Universities Upper aerodigestive tract cancer Urogenital Cancer Voting Woman Work Writing abstracting active method anticancer research arm authority base bench to bedside cancer care cancer epidemiology cancer prevention cancer research center director cancer therapy data management drug development expedited review falls follow-up gastrointestinal high risk improved informatics shared resource interest leukemia malignant breast neoplasm medical appointment meetings member oncology patient population patient safety phase 3 study programs quality assurance research and development response safety study satisfaction sound standard of care therapy development treatment trial tumor working group

项目摘要

The Protocol Review and Monitoring System (PRMS) is an essential component for the conduct of clinical cancer research at the UNM Cancer Center. The PRMS serves to scientifically review and then monitor clinical oncology protocols at the UNM Cancer Center, under the overall supervision of the Clinical Research Committee of the UNM Cancer Center. This Clinical Research Committee serves to supervise and integrate all clinical oncology research efforts at the UNM Cancer Center. The PRMS is made up of two major components, the Protocol Review Committee (directed by Royce) and the Protocol Monitoring Committee (directed by Muller). The Protocol Review Committee (here termed the Medical and Scientific Review Committee) reviews clinical oncology protocols for scientific feasibility and merit. There were 112 protocols submitted for scientific review at the UNM Medical and Scientific Review Committee. Of these 6 were declined by this Committee, and 14 protocols were withdrawn. There were 100 protocols scientifically approved and submitted to Institutional Review Boards for ethical review. In the FY 2008/9, 111 protocols were approved by Institutional Review Boards, and 103 protocols of these were activated for patient accrual. The Protocol Monitoring Committee follows clinical protocols after they are open for accruals, adverse events, and endpoints. This committee has the authority to close protocols if appropriate based on accrual, adverse events, and other rationales. The Protocol Monitoring Committee closed 16 protocols, mainly for poor accrual, while others were closed by the Sponsor or Principle Investigator or by reaching target accruals. In summary, the responsibilities of the PRMS include: 1) Defining and implementing review criteria for all new cancer research protocols, 2) Reviewing the on-going progress of protocols to assure timely and effective performance, 3) Nominating eligible protocols for Protocol-Specific Research Support, and 4) Promoting multi-disciplinary integration of Cancer Center clinical and translational research.

方案审查和监测系统 (PRMS) 是新墨西哥州癌症中心开展临床癌症研究的重要组成部分。 PRMS 在新墨西哥州癌症中心临床研究委员会的全面监督下，负责科学审查并监测新墨西哥州癌症中心的临床肿瘤学方案。该临床研究委员会负责监督和整合新墨西哥大学癌症中心的所有临床肿瘤学研究工作。 PRMS 由两个主要部分组成：方案审查委员会（由 Royce 领导）和方案监测委员会（由 Muller 领导）。方案审查委员会（此处称为医学和科学审查委员会）审查临床肿瘤学方案的科学可行性和优点。共有 112 项方案提交给新墨西哥大学医学和科学审查委员会进行科学审查。其中 6 项被该委员会拒绝，14 项协议被撤回。有 100 项方案经过科学批准并提交给机构审查委员会进行伦理审查。 2008/9 财年，有 111 项协议经机构审查委员会批准，其中 103 项方案已被激活以用于患者累积。方案监测委员会在临床方案开放应计费用、不良事件和终点后遵循临床方案。该委员会有权根据应计费用、不良事件和其他理由在适当的情况下关闭协议。方案监测委员会关闭了 16 个方案，主要是因为应计项目较差，而其他方案则是由申办者或主要研究者或达到目标应计项目而关闭。总之，PRMS 的职责包括： 1) 定义和实施所有新癌症研究方案的审查标准，2) 审查方案的持续进展，以确保及时有效的执行，3) 为特定方案提名合格的方案研究支持，4) 促进癌症中心临床和转化研究的多学科整合。