Clinical Research Services

临床研究服务

基本信息

批准号：
7714435
负责人：
ALEX A. ADJEI
金额：
$ 13.18万
依托单位：
ROSWELL PARK CANCER INSTITUTE CORP
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-07-28 至 2013-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7714435
关键词：
Adverse event Amendment Area Basic Science Biometry Budgets Cancer Center Support Grant Charge Clinical Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Closure Collaborations Collection Communication Consent Forms Data Databases Development Diagnosis Disorder by Site Doctor of Philosophy Education Electronics Ensure Guidelines Health Services Research Housing Intake Intervention Studies Investigational Drugs Location Mediation Participant Phase Postdoctoral Fellow Principal Investigator Procedures Process Protocols documentation Radiation Range Regulatory Affairs Reporting Research Research Ethics Committees Research Personnel Research Priority Resource Sharing Resources Review Committee Role Roswell Park Cancer Institute Safety Scheme Services Site Specimen Standards of Weights and Measures Supervision Suspension substance Suspensions Time Tissues Translational Research cancer prevention clinical research site programs research study response

项目摘要

Clinical Research Services (CRS) is a CCSG Resource critical to the execution of the clinical and translational research programs of Roswell Park Cancer Institute (RPCI). CRS is a comprehensive program that provides a full range of research services for all RPCI investigators at all RPCI clinical sites and in the clinical sites of its affiliates. It is directed by Joyce Yasko, PhD, VP Clinical Research Administration and Services and overseen by Alex Adjei, MD, PhD, Associate Director for Clinical Research. CRS provides resources and oversight for the development, review, implementation, and conduct of clinical research studies; tracks regulatory documents and submits studies and amendments to the Scientific Review Committee (SRC) and Institutional Review Board (IRB) and continuing reviews to the IRB. Dr Yasko defines the role and responsibilities; establishes the standard operating procedures and facilitates the orientation and ongoing education of the CRS staff. CRS includes 40 FTE Clinical Research Coordinators under the supervision of Linda Schmieder, RN, MSN, Director, Study Implementation; 12 FTE regulatory research associates under the supervision of Julie Haney, RN, BS, Director, Study Submission and Regulatory Affairs and 6 FTE compliance staff under the supervision of Janet Pantano, RN, BSN, Director, Compliance. In addition, CRS has a Clinical Research Network under the supervision of Mary Eileen McPhee, RN, MSN, Director, RPCI Clinical Research Network. The Network is responsible for the implementation of clinical research in locations external to RPCI. CRS also provides support for the SRC, Response Review Committee, Phase I Committee and the Data and Safety Monitoring Board; prepares, negotiates and manages study budgets; provides study sponsors and regulatory agencies with all required study documents; coordinates the conduct of all RPCI studies and ensures that complete and accurate study data are collected and entered into a centralized electronic research database (eRT). CRS also ensures that all adverse events are reported promptly and accurately. In CY 2006, CRS managed 256 active intervention studies with an accrual of 906 participants and 233 non-intervention studies with an accrual of 11,953 participants. $155,187 in CCSG support is requested, representing 3% of the total operating budget.

临床研究服务 (CRS) 是 CCSG 的一项资源，对于临床和临床研究的执行至关重要。罗斯威尔帕克癌症研究所 (RPCI) 的转化研究项目。 CRS 是一个综合性计划为所有 RPCI 临床中心和研究中心的所有 RPCI 研究人员提供全方位的研究服务其附属公司的临床中心。它由临床研究管理副总裁 Joyce Yasko 博士指导由临床研究副主任 Alex Adjei 医学博士、哲学博士提供服务和监督。 CRS 为制定、审查、实施和实施提供资源和监督临床研究；跟踪监管文件并向科学报告提交研究和修订审查委员会 (SRC) 和机构审查委员会 (IRB) 以及对 IRB 的持续审查。博士 Yasko 定义角色和职责；建立标准操作程序并促进 CRS 员工的入职培训和持续教育。 CRS 包括 40 名 FTE 临床研究协调员在 Linda Schmieder（注册护士、MSN、研究实施总监）的监督下； 12 FTE 监管研究助理，在 Julie Haney（注册护士、理学学士、研究提交主任）的监督下监管事务部和 6 名 FTE 合规人员在 Janet Pantano（注册护士、BSN、总监）的监督下遵守。此外，CRS 还拥有在 Mary Eileen 监督下的临床研究网络 McPhee，注册护士，MSN，RPCI 临床研究网络总监。该网络负责在 RPCI 之外的地点实施临床研究。 CRS还为SRC提供支持，响应审查委员会、第一阶段委员会以及数据和安全监测委员会；准备，协商和管理学习预算；为研究赞助商和监管机构提供所有必需的研究文件；协调所有 RPCI 研究的进行并确保研究完整且准确数据被收集并输入到中央电子研究数据库（eRT）中。 CRS 还确保所有不良事件均得到及时、准确的报告。 2006 年，CRS 进行了 256 次主动干预累计 906 名参与者的研究和 233 项非干预性研究，累计 11,953 名参与者参与者。请求 CCSG 支持 155,187 美元，占总运营预算的 3%。