Course Summary

The work of analytical laboratories in examining biological samples is crucial in the diagnosis and treatment of patients, in public health screening, and in clinical research. Various published guidelines and consensus standards set out criteria that laboratories should meet to provide assurance of the quality of the data and reports that they generate.

This course, focusing on the work of laboratories that examine samples collected from subjects in the course of clinical trials, compiles relevant quality criteria under the title of Good Clinical Laboratory Practice (GCLP). Compliance with GCLP will assist your laboratory in providing assurance of the accuracy and reliability of its findings to stakeholders in clinical research, including regulatory authorities.

Who will benefit from this module?

This module provides essential learning for all personnel of clinical/medical laboratories, especially those engaged in the examination of samples from subjects participating in clinical trials.

Learning Objectives

• Identify guidelines and standards relevant to GCLP
• Describe various elements of laboratory organization, including quality management, documentation, personnel, safety, equipment, and test materials
• Outline the contents of an analytical plan, and identify important considerations in the management of samples
• Contribute to method validation, performance verification, and quality control of examination processes
• Follow guidance on the reporting of results and the storage of records
• Discuss the roles of error management, audits, external quality assessment, certification and accreditation, and regulatory inspections

Module Outline

Key topics covered in this module include:

• Organization of the laboratory
• Pre-examination processes
• Sample examination
• Post-examination processes
• Error management and quality assessment