Medidata is conducting a study to comprehend the regulatory positions, adoption and the variability with regards to digital informed consent (eConsent) all around the world. This physical exercise has occur about thanks to the substantial variety of regulatory pertinent inquiries Medidata will get from sponsors and corporations controlling trials in investigation. The lifetime science sector is keen to have the solution to leverage digital usually means for consenting demo participants but are uncertain of the regulatory positions on the matter. The only way to search for clarity on this matter was to specifically interact with pertinent authorities.
The study to begin with focused on the countries in the European geographic location but has progressed to other regions like Asia Pacific and the Americas. The study prioritized countries the place there was an aspiration to employ digital informed consent by corporations working clinical trials.
This white paper is the 1st in a series to provide an overview of results from the Medidata eConsent study as it progresses and as we achieve even more comments from pertinent bodies. This paper highlights the essential themes that a variety of bodies have so far communicated.