eConsent Success in Pediatric Trials: Managing Complex Language Requirements

This case study highlights how Signant's SmartSignals eConsent solution successfully addressed the unique challenges of a Phase II pediatric psychiatry trial in Japan. The solution elegantly handled multiple language requirements—using different Japanese character sets for children (Hiragana) and adults (Kanji)—while managing eight distinct consent forms for over 300 patients across 60+ sites.

Key implementation successes included:

• Advanced document management with appropriate translations for different age groups
• Separate access accounts for pediatric patients and parents/guardians
• Signant's creative team designed age-appropriate animations and multimedia to increase engagement and comprehension
• Efficient tracking of multiple consent form statuses to optimize enrollment visibility

As a result, 88% of sites utilized the eConsent solution, 67% of signatures were completed electronically, and 86% of sites chose electronic signatures over alternatives.

For clinical operations directors managing complex multinational or pediatric trials, this case study demonstrates how digital consent solutions can effectively address regulatory compliance while improving the consent experience for diverse participant populations.