Bring Your Own Device (BYOD) eCOA – Instrument Validation Methodology

Current guidance from the FDA and ISPOR (2009) recommends that when a Patient Reported Outcome (PRO) instrument is migrated between different modalities (for example, from a paper PRO to an electronic (ePRO) format), empirical evidence is required in order to demonstrate that the measurement properties of the ePRO application are comparable if not superior to the original PRO format.

This webinar discusses how we can develop a methodology and minimum standards for migrating instruments that would be applicable to any device. 

The objectives of this webinar are to:

• Introduce the concept of BYOD in eCOA
• Describe regulatory expectations and current best practices in PRO migration to electronic devices
• Highlight the challenges that the current regulatory environment poses to BYOD
• Provide an in-depth case study of developing a process to migrate a specific instrument, the ACTS, to electronic format.
• Present the process that was developed for migrating this instrument.