Providing Clinical Study Data to the Office of Vaccines (2of4) Tech Conformance – Jul. 13, 2017

CBER’s Brenda Baldwin and Kirk Prutzman discuss timing of submission of CBER Study Data Standardization Plan (SDSP) checklist and annotated Case Report Form (aCRF) for Study Data Tabulation Model (SDTM). They also cover use of SDTM DOMAINS for vaccine clinical study data, how errors have occurred in SDTM datasets and how to avoid them, and the traceability of data.

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