FDA PRO Guidance Compliance: Practical PRO/ePRO Instrument Equivalence Trips

Source: CRF Health

We discuss some background information on validation and the process for PRO development, FDA PRO guidance and its impact on ePRO usage, some issues to keep in mind and how to avoid them, CRF Health's 4-step ePRO validation program, and case studies. Our guest speakers are Kai Langel and Diane Wild.