I’m Thierry Hillewaere, global product marketing lead at EvidentIQ and I recently met with Manuel Neukum, Chief Operating Officer at EvidentIQ.
Over the past years eConsent software, which helps trial participants to read and sign informed consent documents online, has exploded in popularity.
The following interview will give us an overview on the current eConsent landscape as well as insights on the EvidentIQ way.
Thierry: What is informed consent and why is it important?
Manuel: First things first. Informed consent is a two-way communication process through which the potential participant receives all the necessary information to make an autonomous decision about whether or not to take part in a clinical trial. If an individual accepts to participate, they must read and sign an informed consent document. Communication between the physician and participant will continue throughout the whole study. As positive outcomes in healthcare settings can’t be guaranteed, informed consent at least ensures patients understand the risks they undertake with treatment. Informed consent creates trust between the doctor and patient and allows patients to make the right decisions for them.
Thierry: When do we need informed consent?
Manuel: Informed Consent is required in most medical settings. With regards to clinical studies, the study can’t start until the document is signed, hence the importance of having an easy and fast way of having access to that.
"The study can't start until the document is signed"
Thierry: What can eConsent do for the informed consent collection?
Manuel: eConsent is a tool that can improve the site staff/patient discussion. Informed consent forms (ICFs) have become increasingly complex, technical and more difficult for patients to understand clinical research objectives. eConsent solves this.
Thierry: Consent is not in an early stage anymore. How does EvidentIQ eConsent offering differs from other?
Manuel: The EvidentIQ eConsent offering adds new avenues and goes beyond what traditional eConsent solution offers. It is for instance possible to leverage EvidentIQs 500K+ patient community scattered across the US and Europe to automate EDC enrollment.
Depending on the trial it is possible for the patient to use any connected device and review materials related to the trial and schedule a live consultation with the study personnel to ask further questions. During that time the patient can be seen and the study staff can share all media interactively and respond to any questions the patient submitted during the initial material reviews.
At the end of that process a 21 CFR Part 11 compliant eSignature can be collected and the patient is enrolled into the EDC system.
"EvidentIQ's eConsent (...) leverages 500k+ patient community scattered across the US and Europe to automate EDC enrollment"
Thierry: What does eConsent do to facilitate the subject’s understanding of the information being presented?
Manuel: To assist the subject in understanding the material, eConsent uses interactive electronic-based technology, which include diagrams, images, graphics, and videos. eConsent can be tailored to the intended audience, taking into consideration the subject’s age, language, and comprehension level.
Thierry: Can participants receive a copy of their eConsent and have easy access to the materials and information presented to them during the eConsent process?
Manuel: The eConsent documents can be retrieved via the eConsent solution and in addition via EvidentIQ connected solutions like EDC.
Thierry: Does your eConsent ensures an absolute authentication feature?
Manuel: A secure eConsent solution is one that provides multiple layers of authentication, whether it be in the form of an OTP or an email verification. A secure solution also provides various methods of document authentication by requiring participants to upload multiple forms of identification such as a state ID, driver’s license, and/or a health card.
Thierry: Does your eConsent enables multi-language?
Manuel: The multi-language feature is helpful when the study that is run has a population that spans across multiple countries. In such cases, a multi-language eConsent accommodates multiple languages for participants to easily comprehend what’s being conveyed in the eConsent form.
Thierry: Can informed consent be withdrawn?
Manuel: You can change your mind at any time, even if you have already started the treatment. The process gets triggered via e.g. the EDC system.
Thierry: Anything else you want to tell us?
Manuel: For more information about eConsent you can visit our website www.evidentiq.com and you can also attend our webinar which will explain more into detail what eConsent can do for the industry and showcase its features. This webinar will take place on November 18th at 5pm (CET). Be sure to subscribe, it is free of charge.
Thierry: Thank you for your time!