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.

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).

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 …

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.

6 天之前 · 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.

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.

2021年10月12日 · 本规范原则规定了良好实验室规范（Good Laboratory Practice，以下简称GLP)的相关术语和定义，以及主要技术规范，包括试验机构的组织和人员、质量保证计划、机构、仪器、材料及试剂、试验系统、试验样品和参照物、标准操作程序、研究的实施、研究结果的报告 ...

Xeno Diagnostics is an accredited, high complexity testing laboratory under the Clinical Laboratory Improvement Act (CLIA) and is also compliant with all Good Laboratory Practices (GLP) and Good Clinical Laboratory Practices (GCLP) requirements.