A number of these assays will indeed fall under the Clinical Laboratory Improvement Amendments (CLIA) regulations as "Laboratory Developed Tests" (LDT) and approaches to validation of such ...

We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials.

CLIA（Clinical Laboratory Improvement Amendments），即临床检验改进修正计划，于1988年被美国国会通过，由医疗保险和医疗补助服务中心 (Center for Medicare & Medicaid Services， CMS)颁布，用于规范实验室的质量管理体系。 在美国，CMS要求所有的临床实验室必须通过CLIA的认证注册，才有权接收并处理血液、体液和组织等人体样本，以用于疾病的诊断、预防、评估和治疗，其提供的检测服务才能向美国政府的医疗保险和医疗补助计划收费。 多个癌种 …

Those of us involved in clinical laboratory medicine must comply with the Clinical Improvement Act (CLIA) of 1988. Those laboratories testing nonclinical specimens in support of FDA and EPA applications or permits must comply with Good Laboratory Practice (GLP).

The FDA-GLP, developed for non-clinical research laboratories, and the CLIA, developed for clinical diagnostic laboratories, are both national regulatory standards. The quality documents developed for international use included the OECD-GLP, ISO 17025:2005, ISO 15189:2007, CLSI GP26-A3 and the JCI clinical laboratory standard, 2nd edition.

2019年1月25日 · Many similarities exist between the Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and the Good Clinical Practice (GCP) Guidelines (International Conference on Harmonisation E6 Good Clinical Practices), such as the requirement for a protocol, training documentation, and data retention.

2008年1月7日 · In this paper, we create a comprehensive description of GCLP utilizing GLP and CLIA as a foundation, augmented with specific guidance from organizations such as CAP and ISO.

2025年3月21日 · GLP (Good Laboratory Practice) and CLIA (Clinical Laboratory Improvement Amendments) differ significantly in their regulatory requirements for biomarker assays due to their distinct scopes and applications.

All methods used for safety or endpoint analyses in clinical trials need to be appropriately validated and demonstrably fit for purpose. Methods defined as waived by CLIA, or methods introduced prior to April 2003, do not require validation .

What is a CLIA/CAP laboratory? The Clinical Laboratory Improvement Amendments (CLIA) regulations are used for any US laboratory which tests patient samples and provide individual results to a physician for the treatment, diagnosis, or assessment of that patient. These regulations require an external verification, like The College of American