Patient Safety Monitoring in International Laboratories (SMILE)

国际实验室患者安全监测 (SMILE)

• 批准号: 10551019
• 负责人: LORI SOKOLL
• 金额: $ 310.36万
• 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: 2021-11-15 至 2022-11-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10551019
• 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将优先考虑确保参与其临床试验并获得可靠的基于实验室的数据的个人的安全和最佳管理，这对于对研究结果的有意义解释至关重要。同样重要的是那些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。该合同对国际实验室中患者安全监控的目的（微笑）是为了提高当前和未来的主要非美国实验室的能力，即参加NIAID的AIDS（DAIDS）支持的临床试验，以符合良好的临床实验室实践标准并产生可靠的测试结果。 该合同将提供一种全面而统一的方法，以评估最初和持续的能力以及准备进行NIAID资助的临床试验方案，通过（1）监视遵守良好的临床实验室实践标准，（2）监控协议指定的实验室测试结果的质量和可靠性，（3）提供了各种培训和培训的实验性培训，并提供了质量的运营方式，（3）实验性培训，（3）实验性培训，（3）实验性培训，（3）实验性的运营方式，（3），（4）实验性培训，（3）实验性的运营方式，（3），（4）实验室的运营范围，（3），（4）质量的运营范围，（3） 系统。