Medidata is conducting a research to have an understanding of the regulatory positions, adoption and the variability pertaining to digital informed consent (eConsent) all-around the planet. This exercising has occur about owing to the intensive variety of regulatory related inquiries Medidata receives from sponsors and organizations controlling trials in investigation. The lifetime science industry is eager to have the option to leverage digital signifies for consenting trial individuals but are unsure of the regulatory positions on the matter. The only way to look for clarity on this matter was to right engage with related authorities.
The research in the beginning focused on the countries in the European geographic location but has evolved to other areas like Asia Pacific and the Americas. The research prioritized countries where by there was an aspiration to employ digital informed consent by organizations running scientific trials.
This white paper is the to start with in a series to deliver an overview of conclusions from the Medidata eConsent research as it progresses and as we attain further feedback from related bodies. This paper highlights the essential themes that different bodies have so significantly communicated.