Medidata is conducting a study to recognize the regulatory positions, adoption and the variability regarding electronic informed consent (eConsent) around the planet. This exercise has appear about because of to the extensive variety of regulatory suitable inquiries Medidata will get from sponsors and businesses handling trials in investigation. The lifestyle science business is eager to have the option to leverage electronic signifies for consenting trial contributors but are unsure of the regulatory positions on the subject matter. The only way to look for clarity on this subject matter was to right interact with suitable authorities.
The study in the beginning concentrated on the international locations in the European geographic location but has progressed to other areas like Asia Pacific and the Americas. The study prioritized international locations where there was an aspiration to make the most of electronic informed consent by businesses running clinical trials.
This white paper is the initially in a collection to give an overview of results from the Medidata eConsent study as it progresses and as we gain more feed-back from suitable bodies. This paper highlights the key themes that different bodies have so far communicated.