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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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TrialMax® ePRO and Medidata Rave® EDC Integration
TrialMax® ePRO and Medidata Rave® EDC Integration

<p>Recorded live March 18, 2010</p>

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ePRO Devices: Practical and Regulatory Considerations
ePRO Devices: Practical and Regulatory Considerations

<p>Recorded live May 20, 2010</p>