Patient Safety Monitoring in International Laboratories (SMILE)

国际实验室患者安全监测 (SMILE)

• 批准号: 10377879
• 负责人: LORI SOKOLL
• 金额: $ 305.32万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-24 至 2021-11-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10377879
• 关键词: Acquired Immunodeficiency Syndrome; Clinical; Clinical Trials; Clinical trial protocol document; Contractor; Contracts; Data; Data Management Resources; Ensure; Funding; Future; Individual; International; Laboratories; Monitor; National Institute of Allergy and Infectious Disease; Protocols documentation; Readiness; Safety; Specific qualifier value; Test Result; Testing; Training; Work; base; 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 的首要任务是确保参与其临床试验的个人的安全和最佳管理，并获得可靠的实验室数据，这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员的安全。 NIAID 旨在实现美国（许可实验室）和非美国研究结果之间的可比性。国际实验室患者安全监测 (SMILE) 合同的目的是提高当前和未来参与 NIAID 艾滋病部门 (DAIDS) 支持的临床试验的大多数非美国实验室的能力，以按照良好的临床实验室实践标准进行测试并产生可靠的测试结果。 该合同将提供全面、统一的方法，通过以下方式评估执行 NIAID 资助的临床试验方案的初始和持续能力和准备情况：(1) 监测良好临床实验室实践标准的遵守情况；(2) 监测方案指定实验室测试结果的质量和可靠性；(3) 为实验室提供各种协助、指导和培训手段，以提高实验室运营质量；(4) 托管和维护现有的电子数据管理 系统。