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  • Need to decide if ASEQ should be required, and if so, should it be unique across all ADQRS datasets, in case they are later combined.
  • Need to develop list of expected variables for all ADQRS datasets.
  • How to handle data sent from a vendor with all scores computed, so there are no separate SDTM/ADaM datasets.
  • Do we need to define baseline in our Best Practices?
  • Should we recommend that each questionnaire be stored in a separate dataset, or leave that up to the sponsor to decide?
  • How much manipulation can be done on AVAL for records coming from SDTM before a new parameter should be used instead of copying QSTEST/QSTESTCD into PARAM/PARAMCD?  For example, what if SDTM only collects character values (<=15 minutes, 15-30 minutes, etc.), but numeric codes are required for analysis- can those go into AVAL?  What would be imputed- the character or the numeric value?  Does this change if we are transforming or reversing collected scores for analysis?