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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资源，对执行临床和 Roswell Park Cancer Institute（RPCI）的研究项目。CRS是一个全面的计划为所有RPCI临床研究中心的所有RPCI研究者提供全方位的研究服务，其附属公司的临床研究中心。它由Joyce Yasko博士指导，临床研究管理副总裁，由Alex Adjei，MD，PhD，临床研究副总监提供服务和监督。 CRS提供资源和监督的发展，审查，实施和进行临床研究;跟踪监管文件，并向科学委员会提交研究和修正案审查委员会（SRC）和机构审查委员会（IRB），并继续对IRB进行审查。博士 Yasko定义了角色和职责;建立了标准操作程序，并促进了 CRS工作人员的定向和持续教育。CRS包括40名FTE临床研究协调员在琳达施米德尔（RN，MSN，研究实施总监）的监督下; 12 FTE法规研究助理，由Julie Haney，RN，BS，研究提交和法规事务部和6名FTE合规人员，由Janet Pantano，RN，BSN，总监监督，合规此外，CRS还有一个由玛丽艾琳监督的临床研究网络 McPhee，RN，MSN，RPCI临床研究网络总监。该网络负责在RPCI以外的地点开展临床研究。CRS还为SRC提供支持，缓解审查委员会、I期委员会和数据和安全性监查委员会;编写，协商和管理研究预算;为研究申办者和监管机构提供所有必需的研究文件;协调所有RPCI研究的实施，并确保完整和准确的研究收集数据并输入中央电子研究数据库（eRT）。CRS还确保及时准确地报告所有不良事件。2006年，CRS管理了256项积极干预措施研究，累计906例受试者，233项非干预性研究，累计11，953例受试者参与者要求CCSG支持155，187美元，占业务预算总额的3%。