LMS

Training on Monitoring & Evaluation Research Capacity Strengthening Activities

Notwithstanding, the underlying concept of GCP, i.e. protection of human subjects and validity of data generated is a sensible idea that all health researchers would aspire to, and that is with no doubt applicable to all health research involving human subjects. Therefore, although some GCP details may not apply to all types of health research involving human subjects, consideration of the basic principles has to be promoted wherever applicable as a means of ensuring the research participants are not exposed to undue risk and that data generated are valid and accurate.

There is thus a need to develop the capacity of the research community to implement concept and principles of good research practices in all health research, by developing knowledge and understanding of these concepts, as well as capacity to assess the level of requirement upon the level of risk, to ensure a fit for purpose quality system.

WHO-TDR has initiated the development of a training course that is expected to impart knowledge and skills on good health research practices (GHRP) related to the conduct of human health research.

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.