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The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.
Summary Description CLIA - Brochure 8 - Proficiency Testing DOs and DON'Ts.pdf English: Clinical Laboratory Improvement Amendments (CLIA) brochure for Proficiency Testing
Summary Description CLIA - Brochure 1 - Updated Regulations Brochure How do they affect my laboratory?.pdf English: A brochure outlining the changes for the 2003 Clinical Laboratory Improvement Amendments (CLIA) regulations.
CLIA may refer to: Chemiluminescent immunoassay; Clinical Laboratory Improvement Amendments; Cruise Lines International Association This page was last edited on 20 ...
Under the CLIA, it is the role of the FDA to assess the complexity of the in vitro laboratory diagnostic tests. [33] Tests are only scored after the FDA has cleared or approved a premarketing request, or upon request. [36] Manufacturers can apply for CLIA waivers during this premarket approval/clearance process.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
Patient safety work product includes any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements (or copies of any of this material), which are assembled or developed by a provider for reporting to a PSO and are reported to a PSO; or are developed by a patient safety organization for the conduct ...
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