TAS::75 0849::TAS CLINICAL TRIALS MONITORING SERVICE

作为IND申办者和资助机构，协助癌症治疗评估项目（CTEP）履行其对食品药品监督管理局（FDA）和HHS法规的责任。临床试验监查服务（CTMS）合同负责：1）为开展1期和选定的2期临床试验的临床研究者提供集中的患者登记、数据管理和监查资源; 2）提供现场审计资源，以确保进行1期和选定的2期临床试验的临床研究者符合联邦法规、政策，和程序;这是通过验证提交的数据和确保方案依从性来实现的; 3）通过与合作组、社区临床肿瘤学计划（CCOP）、癌症试验支持单位（CTSU）和其他选定的多机构联合体进行共同现场访问，确保遵守CTMB稽查指南; 4）向癌症治疗和诊断部（DCTD）保证，参与使用DCTD申办的IND药物的临床试验的癌症中心或单个机构/资金符合联邦法规、政策和程序;以及5）通过行政和审计支持确保与DCTD合作的国际团体/机构符合药物临床试验质量管理规范（GCP）和国际协调会议（ICH）标准。

To assist the Cancer Therapy Evaluation Program (CTEP) in fulfilling its responsibilities to the Food and Drug Administration (FDA) and HHS regulations as an IND sponsor and funding agency. The Clinical Trials Monitoring Service (CTMS) contract is responsible for: 1) providing a centralized patient registration, data management, and monitoring resource for clinical investigators conducting phase 1 and selected phase 2 clinical trials; 2) providing an on-site auditing resource to assure that clinical investigators conducting phase 1 and selected phase 2 clinical trials are in compliance with Federal regulations, policies, and procedures; this is accomplished by verifying submitted data and assuring protocol compliance; 3) assuring the adherence to CTMB audit guidelines through co-site visits with the Cooperative Groups, the Community Clinical Oncology Program (CCOP), the Cancer Trials Support Unit (CTSU), and other selected multi-institutional consortium; 4) assuring the Division of Cancer Treatment and Diagnosis (DCTD) that Cancer Centers or single institutions participating in clinical trials utilizing DCTD sponsored IND agents/funds are in compliance with Federal regulations, policies and procedures; and 5)assuring through administrative and audit support that international groups/institutions collaborating with DCTD are in compliance to Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) standards.