Overview: Paper consent vs. eConsent
Here we examine the differences between traditional paper-based consent forms to electronic consent. As technology continues to shape the way we engage with information, organisations are increasingly exploring digital solutions to streamline processes and enhance user experiences.
| Subject | Paper | eConsent |
|---|---|---|
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Several studies have consistently demonstrated that a significant number of participants frequently face challenges in comprehending the full scope of a study due to the extensive written information provided on paper. Moreover, these studies have found that the crucial interaction and subsequent conversation aimed at addressing participant inquiries and concerns commonly occur during in-person sessions. This reliance on face-to-face communication restricts the opportunities for participants to seek clarification and engage in meaningful discussions regarding the study, potentially hindering their complete understanding of its implications. |
eConsent offers an interactive, synchronous or asynchronous process, which can include possible animations, videos and questionnaires, which makes it easier to inform participants more comprehensively and at their own pace and comfort. And if suitable, remotley out of the clinic environment. |
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No audit trail, manual tracking of actions. |
Complete digital audit trail for all signatures and initials, stored in a secure system. |
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Manual version control of consent forms, which, in practice, can be very error-prone. |
Strict version control, automatic verification of most recent version and notifications for required signatures. |
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A lot of work, difficult to know which participants have to give permission again, greater chance of errors. |
System registers which documents require reConsent and updates the status of affected patients. |
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Monitor must be physically at the location or site. |
Remote monitoring can be achieved via system export or video screen-share between staff and monitor, or by direct access for the monitor. |
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Need a lot of folders and storage space, the original document has legal coverage. |
All data is digitally available and backed-up in a secure environment. |
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Many administrative actions are required, such as printing, copying, scanning, sending and storing etc. In addition, the process is difficult to follow with an excel tracker. |
A digital process is easier to follow and automate. In addition, protocol deviations can be prevented more easily. |
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Manual process to confirm form readiness. |
Online overview and reporting of all consent documentation, promotes audit and monitoring readiness. |
Summary
Electronic consent offers significant advantages over traditional paper-based consent in clinical trials. By transitioning to electronic consent processes, researchers can leverage technology to enhance participant understanding, streamline administrative tasks, improve data accuracy, and promote overall efficiency.
Partner with Your Research to revolutionise your clinical trials with electronic consent. Together, we can streamline enrolment processes, enhance participant engagement, and drive transformative advancements in research.
