Laboratories are a fundamental source of scientific evidence critical for clinical research and decision making in clinical diagnostics and patient care. High quality laboratory results derived from the analysis of samples collected from clinical trial participants are a key part of the clinical trial process. They provide critical data that is used for evidence-based decision making about an investigational medicinal product’s safety, efficacy and mechanism of action, and to improve standard care. This data is also required to protect the health and safety of the clinical trial participants. Because of this, it is essential that laboratories meet quality and management standards so that the results they produce are unbiased, accurate and complete.
Good Clinical Laboratory Practice (GCLP) is a set of standards that provide guidance on implementing Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) principles to the analysis of samples from a clinical trial. GLP is a quality system that covers the organisational process and the conditions under which non-clinical laboratory studies are planned, performed, monitored, recorded, archived and reported (OECD 1998). This with the aim of promoting the generation of valid, high quality test data. On the other hand, GCP is an international ethical and scientific quality standard for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting clinical trials that involve the participation of human subjects. Compliance with this standard provides assurance that the data and reported results are credible and accurate, and that the rights, safety and confidentiality of trial subjects are protected (ICH 1996 GCP Guideline).
By combining the GLP and GCP sets of guidelines, GCLP ensures the quality and reliability of the clinical trial data generated by laboratories. Consequently, GCLP is critical for clinical trial laboratory operations and it is expected that compliance with the GCLP standards, monitored annually by external audits, will help laboratories to maintain clinical trial data integrity, provide safety to the study participants and produce effective results that are consistent, auditable and repeatable.
GCLP provides a bridge between GCP and GLP. It is also a framework in which organisations can base to develop facilities, systems and procedures that guarantee the laboratory work and results fulfil the GLP and GCP expectations.
GCLP encompass all aspects of clinical trial laboratory operations, namely: organisation and personnel; facilities; equipment, materials and reagents; standard operating procedures; planning of the work; sub-contracting; trial materials; conduct of work; reporting results; quality control & quality audits; storage and retention of study records and reports; and confidentiality.
There are many benefits to laboratories that are GCLP compliant, the main benefits include:
- Laboratory results (research or diagnostic) that are reliable, reproducible and auditable
- The incidences of false negatives and false positives are reduced
- Results are assured to be of the highest quality
- Results are comparable to those obtained in other compliant laboratories around the world
- Building the confidence of staff, sponsors and clients
- Resources are efficiently managed therefore minimising waste
- Uniformity and standardisation of systems
If you want to learn more about GCLP and the different aspects it involves or would like to get access to GCLP training materials, here you can find a set of Power Point presentations about this topic, kindly shared by the KEMRI-Wellcome Trust (Kilifi, Kenya). To download the presentations simply click on the links in the list below:
- Module 1. Goals, objectives and introduction
- Module 2. Laboratory organisation and personnel
- Module 3. Laboratory facilities
- Module 4. Laboratory equipment
- Module 5. Laboratory standard operating procedures
- Module 6. Laboratory reagents, kits and materials
- Module 7. Laboratory procurement and inventory
- Module 8. Sample management
- Module 9. Good documentation practice
- Module 10. Quality control
- Module 11. External quality assessment
- Module 12. Laboratory validations
- Module 13. Laboratory information management system
- Module 14. Laboratory errors and corrective action preventive action
You can freely use, edit and distribute these GCLP training presentations for non-commercial purposes; please reference Global Health Laboratories and The Global Health Network when you do.
To read about the history of GCLP click here.