Patient Safety Monitoring in International Laboratories (SMILE)

NIAID将确保参与其临床试验的个人的安全和最佳管理以及获得可靠的基于实验室的数据放在首位，这些数据对研究结果的有意义的解释至关重要。同样重要的是进行实验室检测的人员的安全。NIAID旨在实现美国（授权实验室）和非美国实验室之间的可比性。生成研究结果。这份国际实验室患者安全监测（SMILE）合同的目的是提高当前和未来非美国实验室的能力。参加国家艾滋病研究所艾滋病司支助的临床试验的实验室按照良好的临床实验室操作标准进行测试，并产生可靠的测试结果。该合同将提供一种全面和统一的方法，通过(1)监测良好临床实验室实践标准的遵守情况，(2)监测协议规定的实验室测试结果的质量和可靠性，(3)为实验室提供各种帮助、指导和培训，以提高实验室操作质量，来评估niaid资助的临床试验方案的初始和持续能力和准备情况。(4)托管和维护现有的电子数据管理系统。

NIAID places the highest priority on ensuring the safety and optimal management of individuals who participate in its clinical trials and on obtaining reliable laboratory-based data critical for the meaningful interpretation of study findings. Equally important is the safety of those who perform the laboratory testing. NIAID aims to achieve comparability between U.S. (licensed labs) and non-U.S. generated study results. The purpose of this contract for Patient Safety Monitoring in International Laboratories (SMILE) is to enhance the ability of current and future mostly non-U.S. laboratories participating in NIAID Division of AIDS (DAIDS)-supported clinical trials to perform tests in accordance with good clinical laboratory practice standards and produce reliable test results. The contract will provide a comprehensive and uniform approach to evaluate initial and on-going capability and readiness to carry out NIAID-funded clinical trial protocols by (1) monitoring compliance with good clinical laboratory practice standards, (2) monitoring the quality and reliability of protocol-specified laboratory test results, (3) providing labs with various means of assistance, guidance and training to improve the quality of laboratory operations, and (4) hosting and maintaining the existing electronic data management system.