Phase 3 Study involving Social Media Recruitment, eConsent and Bring Your Own Device ePRO

Background

  • More than 1,000 patients pre-screened in under 4 weeks
  • Electronic informed consent / assent for volunteers, parents and guardians aged 13 and over
  • Daily Diary for 12 months

Functional Scope

  • Clinpal Presence as landing page for sites and patients
  • Clinpal Recruit for pre-screener, referral tracking and patient engagement
  • Single system recruitment involving social media ads, a call center, sites and clinics all coordinated through the platform
  • Diary structure:
    • Minimal daily impact to volunteers – rapid start-up and data entry
    • Rewards enabled patient to recognise the value of their diary completion
    • Reminders with push notification ensured adherence and compliance

Results

  • Only Clinpal offered recruitment, electronic informed consent and patient diaries within one system
  • Rapid effective social media based recruitment and screening support by Clinpal configured with call centre workflow
  • Effective automated consent / assent based on candidates age combined with separate parent/ guardian consent for adolescents
  • Complex US State by State difference demanded extensive parameterisation
  • Clinpal’s ability to handle multiple versions (eICF / Diary) critical to support changing requirements
  • Visual dashboard on diary completion and compliance highlighted sites / patients requiring action

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