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.