Patient Safety Monitoring in International Laboratories (SMILE)

国际实验室患者安全监测 (SMILE)

• 批准号: 10788147
• 负责人: LORI SOKOLL
• 金额: $ 317.1万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-11-15 至 2023-11-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10788147
• 关键词: Acquired Immunodeficiency Syndrome; Clinical; Clinical Trials; Contractor; Contracts; Data; Data Management Resources; Ensure; Funding; Future; Individual; International; Laboratories; Licensing; Monitor; National Institute of Allergy and Infectious Disease; Protocols documentation; Readiness; Safety; Specific qualifier value; Test Result; Testing; Training; Work; clinical trial protocol; electronic data; improved; operation; patient safety

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.

NIAID将确保参与其临床试验的个人的安全性和最佳管理以及获得可靠的实验室数据作为最高优先事项，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。NIAID旨在实现美国（许可实验室）和非美国生成的研究结果之间的可比性。本国际实验室患者安全监测（SMILE）合同的目的是提高目前和未来参与NIAID AIDS分部（DAIDS）支持的临床试验的大多数非美国实验室的能力，以根据良好临床实验室规范标准进行测试并产生可靠的测试结果。 该合同将提供一个全面和统一的方法来评估初始和持续的能力和准备，以执行NIAID资助的临床试验方案，通过（1）监测符合良好临床实验室规范标准，（2）监测方案规定的实验室检测结果的质量和可靠性，（3）为实验室提供各种援助手段，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。