m MinJi
on

 

Hi, I have a question about sensitivity analysis in SDTM.

After database lock, without unlock process, we want to modify SDTM using hard-coding in case that data is required to be unlocked.

We think sensitivity analysis will be performed based on ADaM instead of SDTM, though the modification is based on raw data.

Please suggest which data (SDTM or ADaM) reflects sensitivity analysis.

Thank you in advance. 

Forums: SDTM

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