Medidata is conducting a study to understand the regulatory positions, adoption, and variability regarding electronic informed consent (eConsent) around the world. This exercise has come about due to the extensive number of regulatory relevant enquires Medidata gets from sponsors and organizations managing trials in research. These organizations are keen to have the option to leverage electronic means for consenting trial participants but are uncertain of the regulatory positions on the topic.
The study initially focused on the countries in the European geographic region countries but has evolved to other regions including Asia Pacific and the Americas. The study prioritized countries where there was an aspiration to run electronic informed consent by organizations running clinical trials.
This is a first in series of white papers looking at the topic of eConsenting in clinical trials focused on the European region.