Clinical Research Services

临床研究服务

• 批准号: 8375966
• 负责人: ALEX A. ADJEI
• 金额: $ 33.09万
• 依托单位: ROSWELL PARK CANCER INSTITUTE CORP
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8375966
• 关键词: Adverse event; Amendment; Basic Science; Budgets; Cancer Center Support Grant; Clinical Research; Clinical Trials Data Monitoring Committees; Collection; Data; Databases; Development; Doctor of Philosophy; Education; Electronics; Ensure; Grant; Institutional Review Boards; Intervention Studies; Location; Mediation; Participant; Phase; Postdoctoral Fellow; Procedures; Process; Regulatory Affairs; Reporting; Research; Research Personnel; Resource Sharing; Resources; Review Committee; Role; Roswell Park Cancer Institute; Services; Supervision; Translational Research; clinical research site; programs; research study; response

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 罗斯威尔公园癌症研究所（RPCI）的翻译研究计划。 CRS是一个综合计划 这为所有RPCI临床站点的所有RPCI调查人员以及在 其分支机构的临床部位。它由乔伊斯·Yasko（Joyce Yasko），博士，副总裁临床研究管理局和 临床研究副总监Alex Adjei，医学博士Alex Adjei的服务和监督。 CRS为开发，审查，实施和行为提供资源和监督 临床研究；跟踪监管文件，并将研究和修正 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定义了角色和责任；建立标准操作程序并促进 CRS员工的定向和持续教育。 CRS包括40 FTE临床研究协调员 在RN，MSN的Linda Schmieder的监督下，研究实施； 12 FTE调节 研究伙伴在RN，BS朱莉·汉尼（Julie Haney）的监督下，研究提交和 监管事务和6名FTE合规人员在珍妮特·潘塔诺（Janet Pantano）的监督下，BSN，董事， 遵守。此外，在玛丽·艾琳（Mary Eileen）的监督下，CRS还有一个临床研究网络 RN McPhee，MSN，RPCI临床研究网络总监。网络负责 在RPCI外部的位置实施临床研究。 CRS还为SRC提供支持， 回应审查委员会，第一阶段委员会和数据和安全监控委员会；准备， 谈判和管理研究预算；提供所有必需的研究赞助商和监管机构 研究文件；协调所有RPCI研究的行为，并确保完整而准确的研究 收集数据并将其输入到集中的电子研究数据库（ERT）中。 CRS还确保 所有不良事件均迅速，准确地报告。在CY 2006年，CRS管理256个主动干预 由906名参与者和233项不干预研究的计费研究为11,953 参与者。 请求$ 155,187的CCSG支持，占总运营预算的3％。