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White Paper: Documentation of PRO Instruments to Meet Contemporary FDA Standards,  August, 2006


Summary

The FDA draft guidance on PROs may make it difficult for researchers to understand the FDA's recommendations on how to justify and appropriately document the intended use of their PRO instruments.  The goal of this paper is to describe what information clinical researchers should consider providing to the FDA to justify the use of a given PRO instrument in some future trial

Download " Documentation of PRO Instruments to Meet Contemporary FDA Stadards "