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

协助癌症治疗评估计划(CTEP)履行其作为IND赞助商和资助机构对食品和药物管理局(FDA)和HHS法规的责任。临床试验监测服务(CTMS)合同负责：1)为进行第一阶段和选定第二阶段临床试验的临床研究人员提供集中的患者登记、数据管理和监测资源；2)提供现场审计资源，以确保进行第一阶段和选定第二阶段临床试验的临床研究人员符合联邦法规、政策和程序；这是通过验证提交的数据和确保遵守方案来完成的；3)通过与合作小组、社区临床肿瘤学计划(CCOP)、癌症试验支持股(CTSU)和其他选定的多机构联盟进行共同现场访问，确保遵守CTMB审计指南；4)向癌症治疗和诊断司(DCTD)保证，利用DCTD赞助的IND代理/基金参与临床试验的癌症中心或单个机构符合联邦法规、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/机构遵守良好临床实践(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.