What is eConsent

Defining eConsent in Clinical Trials

The US Food and Drug Administration (FDA) has defined electronic informed consent (eConsent) in clinical trials as “the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive websites, biological recognition devices, and card readers, to convey information related to the study to obtain and document informed consent.”

How does eConsent Work in Clinical Trials?

Delve Health’s Clinical StudyPal is a customizable solution that can be integrated into virtually any system or wearable device. Our platform is web-based and offers eConsent, in addition to other features and benefits.

Clinical StudyPal can be utilized to send the eConsent form that the prospective study participant would complete the form or survey questions and add their digital signature. Everything is captured directly via our electronic data capture (EDC) system.

Why You Need eConsent For Your Clinical Studies?

Clinical StudyPal’s eConsent feature automates the patient enrollment process and on-boards patients directly into our platform.

The importance and benefits of eConsent include, but are not limited to:

  • Efficient use of time via automation, leading to a reduction of costs
  • Automation also speeds up the study’s start-up process
  • Reduces informed consent errors
  • Unique ability to consider multiple government regulations
  • Ability to configure for multiple language, increases the chances to reach a diverse population
  • Remote consent monitoring/remote patient monitoring
  • Creates a seamless and user-friendly experience, increasing patient compliance and patient retention
  • Guaranteed signature compliance

eConsent can lead to a transformative experience for study participants by providing simple, easy-to-comprehend clinical trial information, which will boost patient engagement and therefore improve the patient experience overall.

How Can Our Site Implement eConsent for Our Study?

You can learn more about eConsent and integrating Delve Health’s Clinical StudyPal solution in order to design decentralized clinical trials by requesting a demonstration here.


remote clinical trials | Delve Health

7 Ways to Increase Clinical Trial Patient Engagement with SMS & Messaging Apps

Most of us agree that a clinical trial’s success depends heavily on patient engagement. The importance of design patient-centric studies cannot be understated. Engaged
eConsent allows for video conferencing.

The Rise of eConsent Forms and its Impact on Patient Recruitment

Informed consent is one of the founding principles of research ethics. Its intent is that human participants can partake in medical research freely (i.e., voluntarily)
Delve Health delivers wearables directly to patients all over the world.

Delivering Devices and Safely Collecting Real-World Data (RWD)

Can we say something more around why we are focusing on collecting raw data from Wearables? Wearables are being implemented in more and more
banner | Delve Health

Are Wearables a Fade OR Are They Our Future?

Wearables in clinical research is a “hot topic” and all the “buzz.” While many people feel it will propel the clinical research enterprise into

What is eConsent

Defining eConsent in Clinical Trials The US Food and Drug Administration (FDA) has defined electronic informed consent (eConsent) in clinical trials as “the use of
Research In The United States | Delve Health

Opportunities In Transforming Clinical Research In The US

Clinical trials are essential for the development of new drugs and treatments. The goal of clinical trials is to find better ways to prevent,