Day: September 3, 2015

In a news release today, it was announced that England approved its first electronic informed consent. There has been quite a lot of discussion regarding use of electronic or computer-based informed consent in clinical trials. The challenges of these I terms of added cost and time for creating one have not been fully addressed. FDA published … Read more

The European Commission (EC) released an  opinion article last week highlighting its expectations on the minimum standards of qualification of GCP inspectors, in particular regarding their education and training. Per the EC, an inspector must have university level education in medicine, pharmacy, pharmacology, toxicology or other fields relevant to Good Clinical Practice principles. In addition, the inspector … Read more