PATIENT SAFETY MONITORING IN INTERNATIONAL LABORATORIES (SMILE)

美国国家过敏和传染病研究所（NIAID），美国国立卫生研究院（NIH），卫生和人类服务部（DHHS）支持与微生物学和免疫学的基本理解相关的研究，导致疫苗，治疗和医学诊断的发展，用于预防，治疗和诊断传染病和免疫介导的疾病。NIAID，艾滋病司要求采用全面统一的方法来评估初始和正在进行的实验室能力，以及在美国境外执行NIAID资助的临床试验方案的准备情况。NIAID最优先考虑的是确保参与其临床试验的受试者的安全性和最佳管理，以及获得可靠的实验室数据，这些数据对于有意义地解释研究结果至关重要。同样重要的是进行实验室测试的人的安全。美国的临床实验室必须符合临床实验室改进修正案（CLIA）的性能标准，并参加各种外部能力验证计划。虽然存在非美国的认证组织和能力验证计划提供者，但这些组织和机构在对临床实验室的要求和监督水平方面存在很大差异。 国际实验室患者安全监测（SMILE）合同的目的是提供一种全面和统一的方法，通过（1）监测实验室是否符合药物临床试验质量管理规范（GCLP），（2）通过评估编码样品组获得的结果，监测实验室可靠地执行方案规定的测试的能力，（3）向实验室提供各种援助手段，指导和培训，以解决和防止GCLP和/或能力验证缺陷的再次发生，以及（4）维护计算机化数据管理系统和文件库，包括实验室性能数据和指导文件。

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS has a requirement for a comprehensive and uniform approach to evaluate initial and on-going laboratory capability and readiness to carry out NIAID-funded clinical trial protocols outside the U.S. NIAID places the highest priority on ensuring the safety and optimal management of subjects 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. Clinical laboratories in the U.S. are required to meet Clinical Laboratory Improvement Amendments (CLIA) performance standards and participate in a variety of external proficiency testing programs. Though non-U.S. accreditation organizations and providers of proficiency testing programs exist, these vary significantly in their requirements and level of oversight of clinical laboratories. The purpose of the Patient Safety Monitoring in International Laboratories (SMILE) contract is to provide a comprehensive and uniform approach to evaluate initial and on-going laboratory capability and readiness to carry out NIAID-funded clinical trial protocols by (1) monitoring laboratories compliance with Good Clinical Laboratory Practices (GCLP), (2) monitoring the ability of laboratories to reliably perform protocol-specified tests by evaluating results obtained with panels of coded samples, (3) providing Labs with various means of assistance, guidance and training to address and prevent recurrence of deficiencies in GCLP and/or proficiency testing, and (4) maintaining a computerized data management system and document library that include lab performance data and guidance documents.