PATIENT SAFETY MONITORING IN INTERNATIONAL LABORATORIES (SMILE)

国际实验室中的患者安全监测（微笑）

• 批准号: 9915631
• 负责人: LORI SOKOLL
• 金额: $ 247.65万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-11-15 至 2019-11-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9915631
• 关键词: Accreditation; Acquired Immunodeficiency Syndrome; Address; Amendment; Clinical; Clinical Trials; Clinical trial protocol document; Code; Contracts; Data; Diagnosis; Diagnostic; Disease; Ensure; Funding; Immune; Immunology; International; Laboratories; Libraries; Mediating; Medical; Microbiology; Monitor; National Institute of Allergy and Infectious Disease; Performance; Prevention; Protocols documentation; Provider; Readiness; Recurrence; Research Support; Safety; Sampling; Specific qualifier value; System; Testing; Therapeutic; Training; United States Dept. of Health and Human Services; United States National Institutes of Health; base; computerized; data management; patient safety; prevent; programs; vaccine development

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.

国家过敏和传染病研究所（NIAID），国家卫生研究院（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，从而开发疫苗，疗法和医学诊断，用于预防，治疗和诊断传染病和免疫介导的疾病。NIAID艾滋病部门需要一个全面和统一的方法来评估初始和正在进行的实验室能力，以及在美国以外执行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。美国的临床实验室需要满足临床实验室改进修正案（CLIA）的性能标准，并参与各种外部能力测试计划。尽管美国。认证机构和能力测试项目的提供者是存在的，它们在临床实验室的要求和监督水平上有很大的不同。国际实验室患者安全监测（SMILE）合同的目的是提供一个全面和统一的方法，通过以下方式评估初始和正在进行的实验室能力和准备情况，以执行niaid资助的临床试验方案：(1)监测实验室遵守良好临床实验室规范（GCLP）；(3)为实验室提供各种协助、指导和培训，以解决和防止GCLP和/或能力测试缺陷的再次发生；(4)维护一个计算机化的数据管理系统和文档库，其中包括实验室性能数据和指导文件。