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The example analysis dataset includes treatment and demographic information drawn from the ADSL, defined in the Metadata Table below. In this example, only some of the required variables, plus important stratification variables from ADSL, are shown. One variable mentioned body surface area (BSA), can be computed and added to ADSL. However, since the subjects are children, their the body surface area changes over time. Therefore, it would probably be better to have a separate dataset to capture represent this over time.


Info

Questions:

  1. Is screening considered visit 1, or is it to include the subject into the study? SDTM team agreed to change to VISIT 1 instead of SCREENING.
  2. Are these Real World Evidence (RWE) studies only or clinical trials?
  3. Should both endpoints be shown in one efficacy dataset or two? I will be showing 3 datasets.
  4. What is a good surface area to use for the child subject?
  5. Should i use Male and 6 years? please advise.

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