Medidata is conducting a review to understand the regulatory positions, adoption and the variability about electronic knowledgeable consent (eConsent) around the globe. This workout has occur about owing to the substantial variety of regulatory related inquiries Medidata will get from sponsors and corporations managing trials in investigation. The daily life science field is eager to have the choice to leverage electronic means for consenting trial participants but are uncertain of the regulatory positions on the topic. The only way to look for clarity on this topic was to specifically engage with related authorities.

The review to begin with targeted on the international locations in the European geographic area but has progressed to other locations which include Asia Pacific and the Americas. The review prioritized international locations the place there was an aspiration to employ electronic knowledgeable consent by corporations running scientific trials.

This white paper is the initially in a series to supply an overview of conclusions from the Medidata eConsent review as it progresses and as we gain more feedback from related bodies. This paper highlights the essential themes that different bodies have so much communicated.

Medidata is conducting a review to understand the regulatory positions, adoption and the variability about electronic knowledgeable consent (eConsent) around the globe. This workout has occur about owing to the substantial variety of regulatory related inquiries Medidata will get from sponsors and corporations managing trials in investigation. The daily life science field is eager to have the choice to leverage electronic means for consenting trial participants but are uncertain of the regulatory positions on the topic. The only way to look for clarity on this topic was to specifically engage with related authorities.

The review to begin with targeted on the international locations in the European geographic area but has progressed to other locations which include Asia Pacific and the Americas. The review prioritized international locations the place there was an aspiration to employ electronic knowledgeable consent by corporations running scientific trials.

This white paper is the initially in a series to supply an overview of conclusions from the Medidata eConsent review as it progresses and as we gain more feedback from related bodies. This paper highlights the essential themes that different bodies have so much communicated.