Informed consent is one of the most fundamental steps in any clinical trial. Yet many organisations still rely on paper forms, manual signatures, and physical archiving to manage this process. eConsent offers a digital alternative that not only streamlines the process but also improves the quality of consent. This blog compares the traditional paper-based approach with modern eConsent solutions.

In the traditional approach, participants receive a written information sheet, read through it, and sign a consent form in the presence of a researcher. The signed form is archived in the patient record and study documentation.

This process is familiar and functional, but it has clear limitations. The paper trail is labour-intensive, errors are difficult to trace, and any protocol change requires the form to be redistributed, re-signed, and re-archived.

With eConsent, the consent process takes place entirely digitally. Participants receive the information document via tablet, computer or smartphone, can ask questions through integrated features, and sign electronically. Every step is captured in a complete audit trail, immediately available for monitoring and inspection.

Paper forms require physical contact between participant and researcher. eConsent enables the consent process to take place remotely, which is particularly valuable for hybrid and decentralised trials. Participants can read the document at their own pace and ask questions without time pressure.

Research by Nishimura et al. (2013) shows that participants who give digital consent are better informed. Digital consent processes make it easier to present information clearly and in a structured way, which supports participant understanding.

Research by Nishimura et al. (2013) shows that participants who give digital consent are better informed. Digital consent processes make it easier to present information clearly and in a structured way, which supports participant understanding.

A digital solution records every moment of the consent process: who read which document, when, and whether questions were raised or answered. This simplifies preparation for regulatory inspections and aligns with the requirements of the eTMF and the ICH-GCP E6(R2) guideline.

eConsent is not a legal requirement in all jurisdictions, but it is the logical next step for most modern trials. It is particularly valuable for multi-site studies, international participants, frequent protocol amendments, or when decentralised participation is involved. For studies where participants have limited digital literacy, implementation requires extra attention to accessibility and support.

ResearchManager’s eConsent module is integrated with the EDC and enables digital signing through ValidSign, a certified platform for electronic signatures.

Key feature highlights:

Multiple signatories per participant. Relevant for studies with minor participants, where parents or guardians can also sign digitally.

Real-time signing status overview. The signing status of all participants is visible at a glance via the eConsent tab in the eCRF, with full audit trail logging.

Configurable per study. Application managers can enable eConsent on a study-by-study basis and set up participant e-mail templates directly from the study configuration.

Role-based access control. Access to eConsent data can be restricted at user level, ensuring only authorised team members can view consent records.

The same technology also supports document-level consent within the CTMS for study-level documents. This set-up, like the eConsent module itself, is available on request via your account manager.

The paper-based consent model has served its purpose. eConsent offers a more reliable, efficient, and fully traceable alternative that meets the demands of modern clinical trials. The initial implementation investment is quickly offset by time savings, improved data quality, and reduced administrative burden.

Want to see how eConsent works within the ResearchManager Clinical Research Suite? Request a no-obligation demo and discover what it can do for your organisation.