Good Clinical Laboratory Practice

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.

MODULES

Following a brief introduction that provides an overview of the course, the training focuses on a series of modules:

  • Personnel and Organization
  • Facilities, Equipment and Supplies
  • Sample Collection and Management
  • Standard Operational Procedures
  • Documents
  • Data Recording and Reporting
  • Method Validation
  • Quality Assurance and Quality Control
  • Laboratory Assessment

The overall training approach used in these modules is based on adult learning principles. The training will be delivered through lectures, discussions, laboratory visit and problem analysis.

PARTICIPANTS

  • Target participants are those who are involved in research/clinical research with laboratory practices such as principal investigators, researchers, laboratory managers, etc.
  • Commitment to complete the online training and attend all days of the workshop (online & offline); and
  • Assigned by the collaborating institutions.

 

Registration Here:

https://bit.ly/RTC_registration_form