What is eConsent in Clinical Trials?

Consenting is often the beginning of the investigator-participant relationship, and an opportunity to build a trusting environment which can ultimately promote trial compliance. Participants should be provided with adequate information about the trial and what will be expected of their participation – a key factor for trial success. 

An eConsent solution should support this process in a face-to-face setting, whether it takes place remotely or in-person, and the participant should always be provided with a medium to ask clarifying questions. To support global studies, the solution must satisfy both global regulatory requirements (including FDA 21 CRF Part 11, ICH E6 (R2), and GDPR), in addition to varying country regulatory requirements for obtaining consent, and the platform must have multi-lingual capability. 

What are the benefits of eConsent? 

Added benefits of the electronic implementation of this process include: 

• Information can be communicated in a more engaging way 
• Ability to break down lengthy documents into bite-sized chunks, supported by multi-media 
• Flagging of sections that the participant has questions about, and knowledge checks to ensure understanding 

All these elements increase the likelihood that a participant truly understands what their participation in the trial will involve and reduce the likelihood of drop-out. This is also a beneficial way to obtain ascent for pediatric studies. 

Discover our eConsent and Consent Management solutions.