Good Clinical Laboratory Practice (GCLP)
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Summary
In 2006, WHO/TDR convened a meeting of organizations engaged in clinical trials in disease endemic countries to discuss the applicability of GCLP guidelines to their work. It was agreed that GCLP would be a valuable tool for improving quality laboratory practice. In line with that agreement, TDR/WHO recently acquired copyright to GCLP guidelines that were originally published in 2003 by a working party of the Clinical Committee of the British Association of Research Quality Assurance (BARQA), with the aim of disseminating them widely in developing countries and developing related training materials. These GCLP guidelines are presented here. Compliance with them will allow clinical laboratories to ensure that safety and efficacy data is repeatable, reliable, auditable and easily reconstructed in a research setting. GCLP guidelines set a standard for compliance by laboratories involved in the analysis of samples from TDR-supported clinical trials.