What is eConsent?

Electronic consent is a digital/ electronic version of a paper consent.

eConsent (electronic informed consent) is a digital way of explaining a clinical trial and obtaining a participant’s consent using electronic devices such as tablets, computers, or smartphones. It allows participants to review study information, ask questions, and provide consent electronically, making the process clearer, more accessible, and easier to document than paper-based consent.

In clinical trials, In clinical trials, electronic consent is applied during the participant consent stage before trial participation begins and prior to any study-related procedures.It allows individuals to review study details on tablets, computers, or smartphones and provide their agreement digitally, making the process easier, faster, and more accessible, particularly in decentralized or hybrid trial setups.

This digital approach is also used when updates are needed, such as changes in the protocol or new safety information. Participants can review the revised information and give consent again electronically, ensuring their agreement is always current and properly documented throughout the study.

Clinion implements electronic consent by providing a secure digital platform where participants can review study information, ask questions, and sign consent forms electronically. The system tracks which version of the consent was signed, the date, and the participant’s status. It also supports re-consenting when protocol updates or new safety information arise. All actions are automatically logged, creating a clear, auditable record of consent, ensuring participants are properly informed and authorized to take part in the trial at every stage.

In practice, electronic consent in Clinion looks like a participant reviewing the study information on a tablet or computer, then signing digitally to confirm their agreement. The system records the consent version, date, and participant status, allowing staff to verify that consent is complete before any study activities begin. If updates are needed, such as protocol changes or new safety information, participants can review the new details and provide their consent again, ensuring the study always has an accurate and up-to-date record of each participant’s agreement.

In practice, electronic consent in Clinion is enabled through Clinion eConsent. Participants are guided through the study details, with clear explanations of risks and benefits, and review the information on their mobile device, tablet, or computer before providing electronic consent within the app.

The consent data is then synced with Clinion EDC, where the system records the consent version, date, and participant status, allowing sites to confirm valid consent before any study activities begin. When protocol amendments or new safety information are released, participants can review the updated explanations and re-consent through the app, ensuring consent records remain current, informed, and audit-ready.

Informed Consent

Electronic Signature

Informed Consent Form

21 CFR Part 11

Re-consent

Clinion eConsent | Electronic Informed Consent for Clinical Trials 
What is eConsent? A Guide to Electronic Informed Consent in Clinical Trials

eConsent