Digital innovation has transformed the way clinical trials operate—and part of that is the informed consent process. eConsent, or electronic informed consent, is gaining traction as a standard for clinical research that prioritizes accessibility, compliance, and participant understanding.
At Remington-Davis, we’ve seen how eConsents simplify trial operations and elevate the patient experience. Whether your trial is decentralized, hybrid, or traditional, adopting eConsent can drive significant improvements such as stronger engagement, cleaner data, and faster study timelines.
eConsent refers to a digital process that allows clinical trial participants to review, understand, and sign informed consent forms electronically—often from their own devices. It’s more than a paperless version of a document. A robust eConsent platform enhances participant comprehension through multimedia tools like explainer videos, interactive glossaries, and comprehension checks.
By integrating real-time alerts and version control, eConsent platforms ensure every participant receives the most current, approved materials. This is particularly critical in studies with protocol amendments or rolling enrollment timelines.
High-quality eConsent solutions are designed to meet regulatory and ethical clinical research requirements, including:
These built-in controls help sites maintain clean documentation, reduce protocol deviations, and simplify site monitoring and sponsor audits.
The traditional, paper-based informed consent process is time-consuming, prone to error, and increasingly out of step with modern clinical operations. Patients must visit the site in person to review lengthy documents—often with complex language—and provide handwritten signatures. Each signed form must then be manually reviewed, filed, and entered into trial systems. If protocol updates occur, site staff must re-consent every applicable participant face-to-face, often delaying the study and overburdening coordinators and patients alike.
This process becomes even more cumbersome across multisite trials or studies involving geographically dispersed populations. Document version control, tracking, and audit preparation fall on the shoulders of sites, increasing administrative overhead and the odds of missed steps.
eConsent eliminates these inefficiencies. By digitizing the process, research sites can reduce protocol deviations and eliminate manual data entry. Forms are automatically version-controlled, securely stored, and accessible for remote review. Participants can sign from anywhere, allowing for faster onboarding and re-consenting when needed. IRBs and ethics committees benefit from quicker document turnarounds and more transparent compliance reporting.
For sponsors and CROs, this leads to cleaner, real-time data and more consistent documentation across sites. For sites, it means less time on paperwork and more time delivering patient-centered care without sacrificing regulatory compliance or data integrity.
Not all eConsent tools are created equal. The most effective platforms include features that make the process intuitive, compliant, and user-friendly for both patients and study staff. These include:
No steps are missed, version control is maintained, and patient understanding is prioritized so they can make informed decisions.
As clinical trial designs increasingly adopt decentralized and hybrid models, the eConsent process has enabled flexibility without compromising regulatory rigor. eConsent allows participants to review and sign consent forms from their own devices, on their own time. This reduces the need for in-person visits and makes study participation more accessible, particularly for patients in rural or underserved areas.
For the team of clinical researchers, the shift from paper forms to electronic forms provides a clearer line of sight into participant status. Consent progress can be tracked in real time across sites and regions, allowing coordinators to follow up promptly and address any compliance issues before they become risks. For sponsors, this centralization of consent data across multiple locations improves oversight and streamlines regulatory reporting, especially when managing large, multisite, or international trials.
Clinical trial success depends on patient enrollment and retention. eConsent helps with both.
eConsent reduces barriers to entry by:
Participants are more informed, and there are fewer screen failures due to misunderstandings or miscommunication.
Once enrolled, participants are more likely to stay engaged when:
The result is better retention metrics, reduced dropout rates, and more reliable study outcomes.
At Remington-Davis, we believe that the informed consent process should never be a barrier to participation in clinical research studies. It should be a clear, empowering step toward advancing research.
By implementing eConsent, we help sponsors meet regulatory standards, simplify study oversight, and deliver a patient experience that emphasizes convenience, clarity, and compliance. Whether you're managing a complex on-site study or launching a hybrid trial, we’re ready to support your success.
Contact us to find out how we can support your team with our proven tools and patient-centric approach.
eConsent enhances patient compliance by making the informed consent process more accessible, understandable, and actionable. Through the use of multimedia explanations, simplified language, and interactive elements, participants gain a clearer grasp of study requirements and procedures. By reducing confusion and improving patient comprehension, eConsent helps participants understand their commitment to the study and follow the protocol more consistently, which directly contributes to higher data quality and overall trial success.
Yes. eConsent platforms are designed to support higher levels of engagement. Participants can flag questions or request clarifications while reviewing clinical trial information at home. Many platforms offer embedded contact tools—such as secure messaging or integrated scheduling features—so study staff can follow up and verify that every participant understands the study before providing consent.
eConsent forms simplify documentation and ensure that every signature, timestamp, and consent update is securely recorded and easily accessible. This complete audit trail reduces the likelihood of missing, outdated, or improperly filed consent forms—common issues that often result in audit findings. By maintaining a complete and compliant consent history, sites and sponsors can respond to regulatory inspections with confidence and transparency.
Yes. While eConsent offers greater flexibility and accessibility, it’s not the only method available. Participants who are unable or prefer not to use digital platforms can still complete paper-based consent forms. These are typically administered in person, with study staff available to explain the materials and answer any questions. Most clinical trial protocols allow for both electronic and paper consent methods, as long as the approach is approved by the IRB and meets regulatory requirements.