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SDTM + ? Rather Not

SDTM + ? Rather Not. Kurt Hellstern. Hands-on GmbH. 1. Add to mother domain. 2. Cut off and verticalize. Domain XX. Domain SUPPXX. Domain+ in SUPPQUAL & CO. Addition of Non-Patient Data. eCRF. Mapping. SDTM. ODM. OK. Not OK. Reason 1: Additions for data analysis  ADaM.

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SDTM + ? Rather Not

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  1. SDTM + ? Rather Not Kurt Hellstern Hands-on GmbH

  2. 1. Add to mother domain 2. Cut off and verticalize Domain XX Domain SUPPXX Domain+ in SUPPQUAL & CO

  3. Addition of Non-Patient Data eCRF Mapping SDTM ODM OK Not OK

  4. Reason 1: • Additions for data analysis  ADaM Mapping SDTM ODM ADaM Additional Info

  5. Reason 2: • our add-on´s not known by FDA nor by buyer of your study data It´s CDISC, not CDCSC!

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