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Good Clinical Laboratory Practice
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.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s) for a period of 180 days after your purchase is complete.
Detailed Course Information
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
Who will benefit from this course
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.
Module Outline
Introduction
Examination of samples – bodily fluids, solid tissue, or excreta – obtained from study subjects plays a crucial role in many clinical trials. The samples may be examined for routine safety screening of subjects or to test the effects of investigational products or other interventions. This introductory session sets out the course’s learning objectives, provides a glossary of terms, and identifies important guidelines and standards.
Organization of the laboratory
In this session, we discuss various elements of laboratory organization, including quality management, documentation, personnel, safety, equipment, and test materials.
Pre-examination processes
In this short session, we address the planning of work and the management of samples.
Sample examination
The examination, or analytic, phase of testing should be carried out in accordance with the clinical trial protocol / analytical plan. In this session, we consider method validation, performance verification, and quality control of examination processes.
Post-examination processes
The laboratory’s product is the information it provides to clients, so reporting of results and management of records are important. In this short session, we discuss these post-examination processes.
Error management and quality assessment
The laboratory should have a process for dealing with errors and near-errors. The quality management system should be subject to periodic auditing, and external quality assessment of the lab’s work should be carried out. In this session, we address these topics plus accreditation and certification and regulatory inspections.
Key points, additional resources, and assessment
The key points made in the course are summarized, additional resources are provided for reference, and learners can take the course’s mastery assessment.
Roles
Laboratory personnel and management
CPD Points
TBC – points will be retrospectively awarded to learners once the course grading is completed (expected 1 CPD Point)
Region
Level
Introductory/Intermediate
Course Study Time
1 Hour
Europe, USA, Other