Informed consent is more than just a signature on a page. It’s about ensuring a participant truly understands expectations by providing clear and adequate information to support them or their caregiver to make an informed decision. Studies utilizing educational videos to support the consent process show dramatic recruitment and retention results.
- Is patient centric: To truly achieve patient-centric informed consent, materials need to be adapted to the needs of the specific trial participants. Converting documents to engaging and clear video content enables them to review the materials at their own pace.
- Reduces site burden: Tools enabling site staff to set a consistent baseline understanding for all participants in a study reduces the burden on the sites and addresses many of the typical questions site staff may receive.
- Increases participant retention: Compared to participants who completed a trial, 35% of those who dropped out said it was difficult to understand the informed consent form. An effective informed consent process ensures participants have a clear understanding about what trial participation entails, and improves retention by setting clear expectations for the participant from the beginning.
"FDA believes that obtaining a research participant's verbal or written informed consent is only part of the process."
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Who Should Watch?
Certificate of Attendance
Time: 1 p.m. ET, 12 p.m. CT, 10 a.m. PT
Duration: 1 hour