Good Clinical Practice in Clinical ResearchJuly 31, 2013 2013-07-31 19:50
Good Clinical Practice in Clinical Research
Good Clinical Practice in Clinical Research otherwise called as ICH-GCP in this context is a worldwide ethical and scientific quality principle(s) to plan, carry out, collection and reporting of clinical trial outcomes that engage human volunteers. Compliance with these principles assures public that the subject’s privilege, protection and safety of human subjects are safeguarded & agreement with the principles that have their birth in the Declaration of Helsinki, and that the data generated and reported out of clinical investigations are trustworthy and true. ICH- GCP comprises of 13 core principles that is applicable to all clinical trials that could affect the wellbeing and interests of human volunteers.
Good clinical practices in Clinical research was developed by the regulatory establishments of the US, EU and Japan in a direction-finding group termed as the Tripartite International Conference on Harmonization (ICH) and came into existence as ‘guidance’ in 1997. The intention was to grant an integrated standard to facilitate the reciprocal acceptance of clinical trial data by their respective regulatory authorities across the globe.
Clinical research personnel engaged in any phase of clinical study work need to be properly qualified to make sure that they fulfill with Good clinical practices in Clinical research. This takes into account the allied departments supporting the clinical trial. There are no recognized qualification/credentials and so it is indispensable to keep up to time records of training activity.