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FDA Guidance Compliance: Practical PRO/ePRO Instrument Equivalence Tips

March 23, 2015

Recorded live April 15, 2010

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.

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Making the Transition from PRO to ePRO: An Industry Perspective
Making the Transition from PRO to ePRO: An Industry Perspective

Members of an industry panel discuss ePRO deployment in clinical studies, including the lessons learned, be...

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Instrument Validation, Psychometric Testing Including a Discussion of FDA Guidance & ISPOR
Instrument Validation, Psychometric Testing Including a Discussion of FDA Guidance & ISPOR

Sonya Eremenco and William Lenderking report on ISPOR ePRO task force discussion, new pub-lication, and dra...