Informed consent is the essential start to your complex and often lengthy clinical trial. But the process goes beyond just getting a signature from your participants.
It’s also about helping them understand the goals of your trial, its risks and benefits, and what’s expected of them while enrolled. With paper informed consent, you leave a lot to chance. Participants have to understand what they’re signing.
Sites must ensure participants are given the correct consent form before study procedures begin.
Paper forms are easily lost, left incomplete, or falsified. That leaves your trial vulnerable to regulatory fines, delays and even failure.
TrialConsent is an intuitive electronic platform for designing, collecting and managing your informed consent process. TrialConsent’s user-friendly and interactive environment simplifies the informed consent experience. Its tiered-learning approach uses text, images, video, and audio narration designed to help participants learn as they advance through the form and improve their comprehension of the trial’s requirements.
Participants can review the consent content at their own pace, look up unfamiliar terms, and flag areas where they have questions, for review with the site staff. Interactive knowledge assessments reinforce the most important information in the consent, and better support comprehension and retention. When participants are ready to give their consent, TrialConsent accepts digitized or handwritten signatures.
At home, participants can securely review their eConsent online to refresh their knowledge and re-consent if necessary, without needing to travel back to the site. Because TrialConsent is digital, every one of these actions is securely recorded with a time-stamped audit trail to maintain data integrity and protect your trial from start to finish.
If participants feel informed and confident, they are more likely to consent to your trial and remain committed throughout its duration. And as TrialConsent supports the unique needs of different learners, it gets participants motivated right from the start reducing the costs associated with study dropouts and low compliance.
We’ve also made TrialConsent simple for Site Staff, Sponsor Teams, and Ethics Committees. TrialConsentDesigner offers users a range of planning and designing options, giving you professional, interactive eConsent forms with no computer programming knowledge required. It's collaborative interface ensures everyone is always working on, reviewing and approving the appropriate consent version. It neatly documents all changes, and it eliminates the risk of deploying unapproved consent forms.
And as your recruitment gets underway, real-time data can be reviewed through innovative visualization tools that give clear impressions of site performance and support smart decision-making about your trial’s operations.
TrialConsent is either available as a standalone solution or can be seamlessly integrated into your TrialMax-powered eCOA study for even greater efficiencies. Ready to learn more? Request a TrialConsent platform demonstration today.