Electronic Informed Consent in Clinical Research

Medidata is conducting a study to understand the regulatory positions, adoption and the variability regarding electronic informed consent (eConsent) around the world. This exercise has come about due to the extensive number of regulatory relevant inquiries Medidata gets from sponsors and organizations managing trials in research. The life science industry is keen to have the option to leverage electronic means for consenting trial participants but are uncertain of the regulatory positions on the topic. The only way to seek clarity on this topic was to directly engage with relevant authorities. The study initially focused on the countries in the European geographic region but has evolved to other regions including Asia Pacific and the Americas. The study prioritized countries where there was an aspiration to utilize electronic informed consent by organizations running clinical trials. This white paper is the first in a series to provide an overview of findings from the Medidata eConsent study as it progresses and as we gain further feedback from relevant bodies. This paper highlights the key themes that various bodies have so far communicated.