CDISC Guidelines for Annotating CRF
CDISC Guidelines for Annotating CRFs Giada Rizzi Chiesi Farmaceutici S.p.A. 2 Presentation Outline • The FDA requirements • CDISC Guidelines Overview and general rules Specific rules with examples • Appearance & format. 3 The FDA reviewer. 4 The FDA requirements “Study Data Specifications”v.1.4 –01 Aug 2007 associated to “Guidance ... ................
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