What is GCLP?
Good Clinical Laboratory Practice (GCLP) is a guideline in using laboratory samples for clinical studies. For some years, it has been internationally recognized that clinical laboratories processing specimens from clinical trials require an appropriate set of standards to guide good practices. Good Clinical Practice (GCP) is not designed for laboratories and Good Laboratory Practice (GLP) focuses only on pre-clinical analyses and not on human samples from clinical trials. Therefore the British Association of Research Quality Assurance (BARQA) suggested in 2003 a guideline to close the gap. It was agreed that GCLP would be a valuable tool for improving and assuring quality laboratory practice in clinical trials. It was recognized that the GCLP Guidelines were not widely available, and it was recommended that WHO/TDR publish the guidelines on its website as the standard for laboratories undertaking samples from TDR-supported clinical trials. The TDR Diagnostics Evaluation Expert Panel (DEEP) has since recommended GCLP as the standard for clinical laboratories involved in the evaluation of diagnostics for infectious diseases. The spirit of this course is to disseminate and share the experience and knowledge on GCLP particularly in developing countries with its limitation in lab facilities.
Center for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada (CTM UGM), Yogyakarta, Indonesia has been designated as a Regional Training Center (RTC) for Health Research by TDR for the South East Asia Region since 2010, with a mandate to improve research capacity skills of researchers in the region. The 1st , 2nd and 3rd batch of Regional Courses on Good Clinical Laboratory Practice (GCLP) were conducted successfully in September 2015, 2016 and 2017, subsequently.
Following a brief introduction which provides an essay writers overview of the course, the training will be delivered through lectures, discussions, laboratory visit and problem analysis which focuses on a series of modules:
- Personnel and Organization
- Facilities, Equipment and Supplies
- Sample Collection and Management
- Standard Operational Procedures
- Data Recording and Reporting
- Method Validation
- Quality Assurance and Quality Control
- Laboratory Assessment
Target participants are those who are involved in research/clinical research with laboratory practices such as principal investigators, researchers, laboratory managers, etc.