eConsent: For More Successful Clinical Trials
The traditional informed consent process is handled on paper (ICF), which can be confusing for the study participants, burdensome for the clinical site staff, and (unfortunately) error-prone. That’s why more and more companies are moving instead to eConsent: a completely digital and interactive approach that enables a trial site to educate participants remotely, and enables a trial participant to conveniently study and sign informed consent documents online.
Designed with the modern participant in mind, the software not only reduces administrative burden, but it supports better participant comprehension and engagement while it improves the efficiency and quality of clinical trials through improved data quality and insight into the patient experience.
There are a number of eConsent solutions available, but you want to pick one that both improves your processes and adapts to a variety of study populations. To do that, here are the features to keep in mind:
Critical Integrations: Since participant information will now be entered into eConsent first, that system must integrate with the Interactive Response Technology (IRT) and Electronic Data Capture (EDC) systems to ensure that subject identifiers match.
User Friendly and flexible: An intuitive interface ensures that it’s easy to use for all participants, especially when it includes features that support patients with special physical considerations (e.g., font controls or accommodations for the visually impaired).
Multiplatform Accessibility: The system should work on a variety of platforms, including mobile devices that enable participants to sign the documents from anywhere (potentially during a virtual office visit).
Adheres to 21 CFR Part 11: As with all electronically stored data, your eConsent solution must be compliant to protect records from theft, loss or damage.
Multilingual: Since clinical trials can include participants from many countries and cultural backgrounds, the eConsent software needs to support a wide array of languages.
Assessment tools: Quizzes and other interactive elements help ensure that the participant completely understands the material.
Supports Multimedia: In addition to assessments, you want the ability to use informative videos, diagrams, glossaries, and other tools to increase comprehension and improve study retention.
Reporting: One of the benefits of an all-digital system is the insight you can gain into your studies, including participation analytics and reporting on participant progress (e.g., how long they spent on each section).
Supports Protocol Amendments: The system should provide easy access to data about ICF form versions and signatures and assist with re-signing participants when necessary.
An eConsent solution will improve quality and efficiency of your clinical trials while reducing labor, errors, and risk. The right solution will better support your study populations, which in turn improves participant comprehension and engagement. Ultimately, investing in eConsent software is the most impactful way to improve your informed consent process.