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WHO Good Clinical Laboratory Practice (GCLP) ISBN 978-92-4-159785-2; Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Quality Assurance, 10: 83–89.
The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.
The CDC Good laboratory practice guidelines for newborn screening recommends that "laboratory specimen retention procedures should be consistent with patient decisions." [ 49 ] Researchers have described the NBS samples as a gold mine representing a patient population that would otherwise be impossible to get. [ 46 ]
Some tests such as a quick test for malaria, do not require a laboratory, a health care setting or professional, or electricity. [10] For each group of tests, the EDL specifies the test's name, purpose, assay format and type of specimen. [6] Supporting WHO Guidelines or publications are linked and brands are not referenced. [6]
The Clinical Trials Facilitation Group (CTFG) of the Heads of Medicines Agency issued a Q&A document in 2017 addressing Good Laboratory Practice (GLP) requirements within the context of clinical trials for human medicines. This document aims to provide clarification and guidance on GLP principles applicable to non-clinical safety studies ...
NAACLS is the primary accrediting body for clinical laboratory programs in the US, though the Accrediting Bureau of Health Education Schools(ABHES) also accredits a handful of programs. [1] Graduates of the ABHES are not eligible for the American Society for Clinical Pathology (ASCP) certification, but are eligible for the American Medical ...
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NABL is a Full member (ILAC MRA signatory) to ILAC [5] as well as APAC Mutual Recognition Arrangements (MRA), [6] based on mutual evaluation and acceptance of other MRA Partner laboratory accreditation systems. Such international arrangements facilitate acceptance of test / calibration results between countries to which MRA partners represent.