Protocol Management

协议管理

基本信息

批准号：
8335552
负责人：
MICHAEL V. SEIDEN
金额：
$ 19.67万
依托单位：
FOX CHASE CANCER CENTER
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-07-21 至 2014-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8335552
关键词：
Adoption Adverse event Antibodies Area Attention Authorization documentation Behavioral Genetics Cancer Center Support Grant Cancer Trials Support Unit Certification Clinical Clinical Nursing Research Clinical Research Clinical Research Associate Clinical Trials Clinical Trials Database Combined Modality Therapy Commit Communication Communities Comprehensive Cancer Center Conduct Clinical Trials Consent Forms Data Development Disease Drug Kinetics Eligibility Determination Enrollment Ensure Ethics Evaluation Evaluation Studies Extramural Activities Fox Chase Cancer Center Foxes Funding Genomics Global Change Grant Growth Guidelines Health Insurance Portability and Accountability Act Hospitals Human Image Individual Informatics Institutional Review Boards Instruction Laboratories Lesion Link Medical Oncology Mission Modality Modeling Monitor Office Management Operative Surgical Procedures Patient Care Patients Peer Review Physicians Population Sciences Population Study Primary Cancer Prevention Principal Investigator Procedures Process Protocol Compliance Protocols documentation Radiation Oncology Radiology Specialty Regulatory Affairs Reporting Research Research Activity Research Personnel Resource Sharing Resources Review Committee Running Safety Sampling Shipping Ships Site Solid Neoplasm Structure Supportive care Surgical Oncology System Time Toxic effect Training Update Work base cancer therapy chemotherapy data acquisition data management epidemiology study human subject protection improved meetings operation organizational structure patient population programs quality assurance research study response sample collection selective prevention treatment trial tumor

项目摘要

The Protocol Management Office (PMO) provides a centralized resource to support the activation and management of all cancer treatment trials conducted at Fox Chase Cancer Center (FCCC), as well as selected prevention, imaging and data/sample collection trials. The PMO also provides scientific and technical review, ensures compliance with regulatory guidelines and standards, manages patient registration, treatment and data management, reporting to outside sponsors and communication with principal investigators and statisticians and collects and prepares pharmacokinetic and genomic samples for processing at FCCC or for shipping to outside sponsors. Sixty-eight investigators have opened clinical trials through the PMO during the last grant period, including 58 with peer-reviewed funding. Investigator Use over the past five years represents use for all five CCSG Programs. Additionally, all investigators at the Center have access to the Protocol Support Laboratory (PSL), a centralized laboratory for sample collection and processing, and the Protocol Specific Monitoring System for study evaluation and monitoring. During a time of reorganization at the Center, institutional support has been provided to several areas to improve and expand key areas in support of the clinical trials program. Specifically, the regulatory affairs team has been expanded to take on additional responsibilities in support of investigators at the Center; the informatics platform was expanded to additional outside affiliates for tracking of enrollment at extramural sites, and additional capabilities were added to enhance reporting and tracking of PMO activity and finally; work has been undertaken to link the database for the clinical trials run by the PMO with that of the Population Studies Facility (PSF). Currently, the PMO is working towards full integration of the Extramural Research Team, which provides monitoring and support to affiliates participating in FCCC-sponsored clinical trials with completion of this project in the next several months.

协议管理办公室（PMO）提供了一种集中资源，以支持在Fox Chase Cancer Center（FCCC）进行的所有癌症治疗试验的激活和管理以及选定的预防，成像和数据/样本收集试验。 PMO还提供科学和技术审查，确保遵守监管指南和标准，管理患者注册，治疗和数据管理，向外部发起人报告以及与首席研究人员和统计学家以及收集和准备药代动力学和基因组样品，用于在FCCC处理或运送到外部赞助商。在上一个赠款期间，有68名调查人员通过PMO开设了临床试验，其中包括58个经过同行评审的资金。在过去的五年中，调查人员的使用代表了所有五个CCSG计划的使用。此外，该中心的所有研究人员都可以访问协议支持实验室（PSL），用于样本和处理的集中实验室以及用于研究评估和监视的协议特定监控系统。在该中心重组的时候，已经向几个领域提供了机构支持，以改善和扩大支持临床试验计划的关键领域。具体而言，监管事务团队已被扩大，以承担额外的责任，以支持中心的调查人员。信息平台扩展到了其他外部分支机构，以跟踪壁外站点的入学率，并增加了其他功能，以增强PMO活动的报告和跟踪，最后；工作有被禁止将数据库链接到PMO进行的临床试验与人口研究机构（PSF）的临床试验。目前，PMO正在致力于全面整合校外研究团队，该团队为参与FCCC赞助的临床试验的关联公司提供了监视和支持，并在接下来的几个月内完成了该项目。