Seeking some advice on the 3 columns in the title "Repeating", "Reference" in the datasets tab and "Mandatory" columns in the variables tab in the P21 spreadsheet to generate the define.xml for ADaM.
"Repeating": if set to "Yes", does it mean the structure of the dataset should be one record per subject only, and so the key structure could be USUBJID only?
"Reference": if set to "Yes", does it means the dataset does not contain subject level data so the key structure would not reference a subject variable like "USUBJID"? Or is it possible to have an ADaM dataset that could be a reference dataset but still use a subject level variable in the key structure (for ex: specific exclusion for analysis at the subject level)? In the last scenario would it be acceptable.
"Mandatory": If set to "Yes", does it mean the variable must be present because the ADaM IG has it as 'Expected' in the guidance and should not have missing value?
* Required Field