Medidata is conducting a examine to realize the regulatory positions, adoption and the variability relating to electronic knowledgeable consent (eConsent) all over the globe. This physical exercise has arrive about because of to the intensive number of regulatory relevant inquiries Medidata gets from sponsors and organizations taking care of trials in exploration. The lifestyle science business is keen to have the selection to leverage electronic indicates for consenting demo members but are uncertain of the regulatory positions on the topic. The only way to request clarity on this topic was to straight have interaction with relevant authorities.
The examine in the beginning focused on the countries in the European geographic location but has progressed to other locations like Asia Pacific and the Americas. The examine prioritized countries where by there was an aspiration to employ electronic knowledgeable consent by organizations jogging medical trials.
This white paper is the initial in a series to give an overview of findings from the Medidata eConsent examine as it progresses and as we obtain additional feedback from relevant bodies. This paper highlights the essential themes that a variety of bodies have so much communicated.