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Many people believe that obtaining informed consent from subjects during a clinical trial is not an issue. They believe that the way they are collecting consent now, via paper-based methods, is effective.
The truth is, obtaining informed consent via paper-based methods is very challenging. Paper puts study teams at risk for regulatory issues, inconsistency in the data, and poor participant comprehension.
eConsent improves the consent process in many ways:
- Date-time stamp functionality reduces regulatory inspections
- Recording participant questions and site personnel responses ensures the subject understood what they were consenting to
- Allowing the subject to pause for breaks, perform check-ins via short quizzes that test their knowledge and comprehension
The fact is, obtaining informed consent IS an issue that study teams are facing regularly, and with so many processes in clinical trials switching from paper to electronic, informed consent is the next solution to improve clinical trials for subjects, sponsors, sites, and anyone else involved in a clinical trial.
Stay tuned for more eConsent myths and the FREE infographic.
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