PAAB LEARNING · MODULE 01 · CHAPTER IVChapter IV: Claims, Evidence & Substantiation
Chapter IV: Claims, Evidence & Substantiation
Examining how primary clinical evidence, comparator context, and measured endpoints define what promotional messages can responsibly say.
Chapter OverviewChapter IV: Claims, Evidence & Substantiation
Previously:
Claims, Evidence & Substantiation
How medical writers test clinical assertions against study endpoints, comparator design, and authorized product context.
Substantiation Architecture 1.The Claim: What is being asserted or implied to the reader?
2.The Evidence: Who was studied, what comparator was used, and what was measured?
3.The Context: Does the statement align with authorized product information and fair balance?