SMART-TRIAL Releases New eConsent Add-On

SMART-TRIAL has released version 2022.1, which includes the brand new Add-On, eConsent, as well as a number of smaller fixes and changes.

The launch of SMART-TRIAL's eConsent Add-On will be the primary focus of the release webinar on Wednesday, February 2nd, 15.00 CET. The webinar will cover key benefits of the new Add-On as well as how to use eConsent efficiently in medical device studies.

Save your spot for the webinar here.

SMART-TRIAL eConsent Add-On

The use of eConsent in medical device studies has been a topic of discussion in the medical device industry for years, and due to Covid-19, study sponsors have been increasingly considering the feasibility of implementing eConsent in the clinical workflow. As remote treatment options are increasing, remote clinical investigations are increasing as well, and Decentralized clinical investigations will always require some type of remote consent solution. Read more about eConsent and best practices in medical device clinical investigations here.

That's why we're extremely proud of launching the SMART-TRIAL eConsent Add-On, which will completely bypass the time-consuming and costly setup required for other available solutions. This will change the way sponsors and CROs can use eConsent in clinical investigations, registries and surveys, by removing some of the main obstacles and making eConsent a far more feasible option when designing the study design.

So, what's new about the eConsent Add-On?

In its essence, the SMART-TRIAL eConsent Add-On allows you to collect consent from subjects electronically, out-of-the-box. You have full control of the setup and can simply enable the add-on when running a study where remote consent could benefit the trial process, which gives you a lot more flexibility on how to obtain consent.

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In short, you can now set up the signing process as follows:

• Subject receives a link to the consent document either by being sent via email/SMS or by scanning a QR code
• One Time Password is sent to subject to access the consent document
• Subject confirms they have read, understood and agreed to what is in the consent document.
• Subject draws or writes their signature
• One time password is sent to the subject to confirm the signature
• Investigator receives an email, that a new document is ready to be countersigned
• Investigator logs in, reviews the signature
• Investigator draws or writes their signature
• Investigator receives a One Time Password
• Document is fully signed
• Subject receives an email with a link to the fully signed document

Please read our help site article for a full write up, and don't hesitate to contact us if you have any questions or are interested in using it.

Other improvements and fixes

To review all other improvements, changes, and fixes, visit the official SMART-TRIAL Changelog.

Thoroughly validated software

For every SMART-TRIAL release we conduct thorough verification and validation of all system requirements. All SMART-TRIAL releases are validated according to SMART-TRIAL’s state-of-the-art quality management system to ensure compliance with relevant industry standards.

For quality assurance, you can download the 2022.1 release certificate here.