Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research.

ABSTRACT: Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of GCLP at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant traini

SUBMITTER: Gumba H 

PROVIDER: S-EPMC6305232 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature