GCLP (Good clinical laboratory practice) Guidance

Published by ECRINThe Asia Pacific Observatory on Health Systems and Policies (APO)

Clinical Trials Toolkit

This guidance identifies systems required and procedures to be followed within an organization conducting analysis of samples from clinical trials in compliance with the requirements of Good Clinical Practice (GCP). It thus provides sponsors, laboratory management, project managers, clinical research associates (CRAs) and quality assurance personnel with the framework for a quality system in analysis of clinical trial samples, ensuring GCP compliance overall of processes and results.

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