Course Overview and Introduction to GCLP

Course Description

This course introduces the systems and procedures required within organisations that analyse samples from clinical trials.

Clinical trials involving human participants in South Africa are subject to regulatory and ethical requirements. Relevant personnel should therefore be familiar with applicable international Good Clinical Practice requirements and the South African Good Clinical Practice guidelines.

The course is aligned with relevant OECD GLP, ICH GCP and SA-GCP principles.

Course Objectives and Learning Outcomes

This course is designed to enable participants to:

• Understand the requirements of Good Clinical Laboratory Practice (GCLP).
• Understand the OECD Principles of Good Laboratory Practice (GLP).
• Understand the ICH Guidelines for Good Clinical Practice (GCP).
• Describe the roles and responsibilities of key personnel.
• Understand how GCLP requirements are implemented in clinical research trials.

Introduction to GCLP

Good Clinical Laboratory Practice (GCLP) applies the principles of Good Laboratory Practice (GLP) that are relevant to the analysis of samples from clinical trials, while also supporting the purpose and objectives of Good Clinical Practice (GCP).

This helps to assure the reliability, quality and integrity of data generated by clinical laboratories.

GCLP provides a unified approach that can be applied globally to:

• support the consistent analysis of clinical trial samples;
• help protect participant safety;
• promote confidence in the data generated; and
• support the acceptance of clinical data by regulatory authorities worldwide.

GCLP is not an accreditation standard in itself. It brings together relevant principles from GCP and GLP and applies them to laboratory activities conducted as part of clinical trials.

Clinical trial laboratories may therefore be assessed or audited against applicable GCP, GLP and sponsor requirements. GCLP should not be confused with accreditation to ISO 15189, although some quality-management principles may overlap.

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