PRO-Measurement

ePRO Services

ePRO Instrument Validation

ePRO Instrument Validation assists sponsors in adhering to the elements of the FDA Draft PRO Guidance regarding demonstrating retained measurement properties of PRO assessments when migrating from one mode of administration to another (e.g., paper to electronic). PRO Consulting plans and implements the validation activities for migrating ePRO instruments, including:

  • Demonstrating that measurement properties have been retained through a clinical trial includes:
    • Writing protocols
    • Obtaining IRB approvals
    • Managing clinical staff for trial execution
    • Creating study documents, e.g., CRFs, etc.
    • Conducting validation activity (cognitive debriefing, equivalence study, psychometric validation study)
    • Data Analysis
    • Writing study reports
    • Summarizing validation activity and recommendations
  • Collaborating with instrument author on conduct of psychometric validation activities (if required)
  • Collaborating on publication of results
Contact us for more information on ePRO Instrument Validation.