Page History

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• AVAL/AVALC
  • Keep QSORRES, and use AVALC only if it differs from QSORRES.
  • Logically skipped items are now being captured in the QRS supplements (2021). We recommend that they are carried over from SDTM for traceability. In this case, the AVAL and AVALC is null, unless someone needs to summarize a count. In the latter case, we suggest to add AVALC of 'Logically Skipped Item' so that it may be counted. These items do not need to be carried over to additional summary datasets.
  • 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 (question codes pre-printed on the instruments).  Author codes should be included in ADaM if present in SDTM.

• Analysis and Baseline Flags
  • Set ANLxxFL and ABLFL only on total score and sub-score records, unless individual items are also summarized.
  • Baseline definitions are analysis-specific, and thus are outside the scope of ADQRS supplements.  Baseline values may still be identified in the examples, but those are not intended to endorse a specific baseline definition.

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