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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?
  • How should author codes (question codes pre-printed on the instruments) be handled?  Sometimes the same question can be used on different instruments that are related;  if the data is being pooled across studies for integration, and some of the items are the same, it may be possible to combine data from those items via the author codes.