Mobile Devices and Wearables: The New Source Document

In this post, CMO Dr. Leigh Mack explains how wearable devices and smartphones will play a major role in the consent process and in patient reported outcomes as clinical trials evolve.

An evolution is happening in clinical research.  The change is the source document. We all remember the test question on the certification exam about recording the participant’s BP on the exam paper; this then becomes the source document and must be treated as such for the trial. This question might be similar to: where should the end of the shafts stop in relation to the horse’s anatomy while hitching up a carriage? Paper documents will go the way of the horse and buggy of yesteryear. Today, computers are much more accurate compared to humans. Yes, humans program software and can make mistakes, but we all use computers in some fashion to make our world more accurate and complete tasks in a more expeditious way.

Now, imagine consenting a potential participant remotely and more effectively. They receive a digital copy of the consent form to review, but they also receive an embedded video explaining the trial; thus, providing a more thorough understanding of the trial. They engage with the CRA in a recorded video, so that they may ask questions and illustrate consent by body language and oral confirmation. The electronic consent (eConsent) is signed and electronically sent directly to the participant file along with the video/audio recording of the consent. In addition, this is all completed on the participant’s end via mobile phone and is 21 CFR Part 11 compliant.

Today, Apple Watch can easily collect physical activity, heart rate, and send reminders to answer questions via RSS and ePRO for a trial diary entry. The human error factor has been removed from the equation. No longer would a participant have to go to a brick and mortar location to have their vitals checked and recorded on a piece of paper, then entered into a computer software system by hand.  The data is simply fed directly to the participant’s eCRF in a safe and secure fashion. The paper trial has two people who enter data; the automated trial has zero.

This technology of tomorrow is in use today.

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