ICH-GCP = International Conference on Harmonization – Good Clinical Practice.
GCP is defined in the ICH guideline as an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. This standard ensures the public that the rights and safety of the trial subjects are protected and that the trial results are credible.

Good Clinical Practice is not something that is widely known. With this series of articles this researcher has tried to give a brief introduction to ICH-GCP and several of its aspects.

The first article gives an historical overview of several issues, which led to what is now known as Good Clinical Practice. With this brief history in mind, the second entry tries to shed some light in the dark and dim world of Clinical Trials. Before a new drug reaches the market, it needs to go through several phases of testing and research. The third article then takes a look at the way such a trial is organised and who is involved. And finally, in the forth article, a more critical look at Good Clinical Practice and Clinical Trials is taken up, with the discussion of the ethical aspect, difficulties which can arise during a trial, political and socio-economical issues…

1. A Brief History
2. Clinical Trials
3. Organisation of a Trial
4. A Critical Approach