Good Clinical Practice TrainingJuly 30, 2013 2013-07-30 19:24
Good Clinical Practice Training
Good Clinical Practice Training:- GCP / ICH-GCP is a worldwide accepted set of scientific and ethical principles for initiating, implementing, gathering and reporting of clinical trial results that involve human beings. The want for accomplishment of these this guideline will assure that the human volunteers safety, rights and well-being are safeguarded based on the principles brought-forth in the Declaration of Helsinki, and that the data reported out of the clinical trials are consistent and accurate.
Good clinical practices in Clinical studies were brought-forth by the regulatory bodies of US, Japan and EU collectively by a dedicated committee namely the Tripartite International Conference on Harmonisation (ICH) and came into force as guidance to pharma industry in the year 1997. The thought behind it is to have a universal standard that allows the mutual approval of clinical trial data by the relevant regulatory bodies across all regions.
Good clinical practice training and certification will qualify the research personnel from any stream to participate in clinical trials.
Clinical trial personnel involved in any stage of clinical research work need to be qualified to make sure that they are able to abide to Good clinical practices. This is appropriate to all concerned divisions supporting the clinical research efforts. James Lind Institute’s Good clinical practice training and certification program is offered in a self-paced and online mode which helps the professionals to know global guidelines and provides necessary certification.