CLINICAL TRIALS MONITORING SERVICE

临床试验监测服务

• 批准号: 3615586
• 负责人: ROBERT B ROYDS
• 金额: $ 33.2万
• 依托单位: THERADEX SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 1988
• 资助国家: 美国
• 起止时间: 1988-06-30 至 1993-06-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3615586
• 关键词: cancer information system; data collection methodology /evaluation; human rights; human therapy evaluation; patient /disease registry

This project contains two objectives that satisfy the Clinical Trials Monitoring requirements of the FDA, HHS, PHS, NIH and the NCI policies and procedures concerning accuracy and quality assurance of data for Phase I Clinical Trials. The two objective are as follows: (1) to establish a detailed patient by patient data base for clinical observations occurring during Phase I trials and to provide regular status report and summary findings in a uniform format. The data base shall provide the Division of Cancer Treatment (DCT), NCI and the Phase I investigators timely information on ongoing studies, and it shall assure the DCT of quality data on all patients from all studies. (2) to provide "site visit" monitoring of each Phase I contractor in order to assure the DCT of the Phase I Principal Investigators' compliance with the NCI policies and the FDA regulations regarding data quality; human protection procedures; and drug storage and accountability.

该项目包含满足临床的两个目标 FDA，HHS，PHS，NIH和 关于准确性和质量的NCI政策和程序 对I期临床试验的数据保证。 两个目标 如下：（1）由患者建立详细的患者 在I期试验期间发生的临床观察数据库 并提供定期的状态报告和摘要调查结果 均匀格式。 数据库应提供癌症的划分 治疗（DCT），NCI和I期研究人员及时 有关正在进行的研究的信息，它应确保DCT 所有研究中所有患者的质量数据。 （2）提供 “现场访问”对每个I期承包商的监视，以便 确保第一阶段首席研究人员的合规性 与NCI政策和FDA有关数据的法规 质量;人类保护程序；和药物存储和 问责制。