Good Clinical Laboratory Practice (‎GCLP)‎

Good Clinical Laboratory Practice (GCLP) is the globally recognized framework that governs laboratory work supporting clinical trials. From sample collection to result reporting, it ensures that every step meets the regulatory and ethical standards required to produce reliable, audit-ready clinical data. This course covers the core GCLP principles and their practical application across the full laboratory workflow.

What you’ll learn?

• Principles and key components of GCLP and its relevance to clinical trials
• Proper sample collection, transport, reception, and storage practices
• Validation, qualification, and fit-for-purpose laboratory methodologies
• Sample analysis, chain-of-custody procedures, and result reporting
• Documentation, archiving, and regulatory compliance requirements

Who should enroll?

• Sponsors
• Laboratory managers and staff
• Project managers and Clinical Research Associates (CRAs)
• Quality assurance and compliance personnel

Upon successful completion, you will receive an internationally recognized GxP Training certificate, accredited with CPD/CEU credits, suitable for audit and compliance documentation.

Curriculum:

Objectives
Introduction
Lesson 1: Good Clinical Practice and the Role of Laboratories in Clinical Trials
Lesson 2: Regulatory Framework Governing Clinical Trial Laboratories
Lesson 3: Laboratory Organization, Personnel, and Responsibilities
Lesson 4: Facilities, Equipment, Materials, and Computerized Systems
Lesson 5: Pre-Examination Phase – Sample Lifecycle Management in Clinical Trials
Lesson 6: Examination Phase – Analytical Methods, Testing, and Validation
Lesson 7: Post-Examination Phase – Data Integrity, Documentation, and Reporting
Lesson 8: Quality Management, Error Handling, and Laboratory Oversight
Conclusion
Evaluation