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.

卫生与公共服务部国家卫生研究院（NIH）国家过敏和感染疾病研究所（NIAID）（DHHS）（DHHS）支持与对微生物学和免疫学的基本了解有关的研究，从而导致疫苗，治疗，治疗和医学诊断的治疗，治疗和诊断性诊断和免疫诊断和免疫诊断和免疫诊断。 NIAID，AIDS的划分需要一种全面且统一的方法，以评估最初和持续的实验室能力，并准备好进行NIAID资助的临床试验方案，以确保对参与其临床试验的受试者的安全和最佳管理，以确保参与其基于实验室基于实验室的数据的最佳管理，并获得了对可靠的基于实验室数据进行研究的研究。同样重要的是那些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）绩效标准，并参与各种外部能力测试计划。尽管存在非美国认证组织和能力测试计划的提供者，但这些组织的要求和对临床实验室的监督水平差异很大。 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样本，（3）为实验室提供各种帮助，指导和培训手段，以解决和防止GCLP和/或熟练度测试中缺陷的复发，以及（4）维护计算机数据管理系统和文档库，其中包括实验室绩效数据和指导文档。