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实验室数据放在最优先位置，这些数据对于有意义地解释研究结果至关重要。同样重要的是那些进行实验室检测的人的安全。NIAID的目标是实现美国(有执照的实验室)和非美国产生的研究结果之间的可比性。国际实验室患者安全监测合同(SMILE)的目的是提高目前和未来参与NIAID艾滋病部门(DAIDS)支持的临床试验的大多数非美国实验室按照良好的临床实验室实践标准进行测试并产生可靠测试结果的能力。该合同将提供一种全面和统一的方法，以评估最初和正在进行的能力以及执行NIAID资助的临床试验方案的准备情况，方法包括：(1)监测良好的临床实验室实践标准的遵守情况，(2)监测方案规定的实验室测试结果的质量和可靠性，(3)为实验室提供各种援助、指导和培训，以提高实验室操作的质量，以及(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.