SDTM ETL 3 1 User Manual and Tutorial Author Jozef Aerts XML4Pharma Last update 2015 05 25 Adding editing and managing links to external documents in define xml Define xml contains the metadata of our SDTM SEND datasets If the define xml 1s intended to be submitted to the FDA there is a so called context of a regulatory submission this also includes references to external documments such as e the annotated CRF as a single PDF file e supplemental document
SDTM ETL 3 1 User Manual and Tutorial Author Jozef Aerts XML4Pharma Last update 2014 08 23 Working with the WhereClause in define xml 2 0 As of define xml 2 0 it is mandatory to define under which circumstances value level metadata 1s used using so called WhereClauses For example for VSORRES the value itself will differ depending on what the value of VSTESTCD is For example when VSTESTCD DIABP diastolic blood pressure we expect the value to be an integ