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sasuser123123
Quartz | Level 8
Hello Everyone.
Could anyone tell me that the 'patient dairy data' goes under which domain in SDTM.

Thank you.
4 REPLIES 4
andreas_lds
Jade | Level 19

Well, i can't. i have no idea what "SDTM" stands for.

Raghupathi
Calcite | Level 5

STUDY DATA TABULATION MODEL

Its standardization of data as per FDA guidelines.

Dataset level, variable level and value level.

Ksharp
Super User

EX  or  EC ?

Sajid01
Meteorite | Level 14

This is more of a study design question. This should be specified in the Clinical Trial Protocol  or Statistical Analysis Plan.
Typically intervention datasets collect /capture information about procedures and treatments given as per protocols. This includes Substance Use (SU) .  This a possible location.
However it all depends on Study design / protocol.

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