Versions Compared

Old Version 8

changes.mady.by.user Nancy Brucken

Saved on

compared with

New Version 9

changes.mady.by.user Nancy Brucken

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

  • Include PARCAT1 in ADQRS datasets in case multiple instruments are subsequently combined into a single dataset.  PARCAT1 contains the name of the instrument, and may come from QS.QSCAT.
  • PARCAT2 is allowed if needed, and should contain the subscale name (may come from QS.QSSCAT, but is driven by analysis/reporting needs).
  • Bring QSTEST and QSTESTCD directly into PARAM and PARAMCD, respectively, for maximum traceability back to QS.
  • Keep QSORRES, and use AVALC only if it differs from QSORRES.
  • Set ANLxxFL and ABLFL only on total score and sub-score records, unless individual items are also summarized.
  • Include at least one treatment variable (TRTP/TRT01P/TRTA/TRT01A) in examples for now, to conform to the latest ADaM IG.
  • Use a completely different PARAMCD value for the computed total score than the SDTM QSTESTCD values.  That makes it easier to spot in the data set, and also distinguishes it from a collected total score that may be stored in SDTM.  For the GDS-SF, this will be called GDSTOTGDS02TS.  A new Controlled Terminology request should be submitted for computed score records.
  • Do not include QS, FT or CC in the ADaM dataset names.  That releases 2 more characters for use in the dataset names.  The GDS-SFdata set will be ADGDSSF.
  • Whether to include responses to all items in the ADQRS datasets, or only summary records being analyzed will be decided on a per-instrument basis, so this information will be included in the ADQRS supplements for the individual questionnaires.  However, the FDA has expressed a preference for including both the individual items and summary records in the same dataset.  They recalculate all of the scores to compare against values provided by the sponsor, and it's easier for them if both individual items and summary records are all in the same dataset.
  • Document instrument scoring instructions in define.xml.
  • Even if SDTM has computed a total score, keep a separate ADaM total score record in the analysis dataset. Also keep the total score from SDTM which has a different parameter.
  • When creating PARAMCD values for subscale scores, keep the SDTM QSTESTCD indicator, and abbreviate any published subscale codes.
  • Use of "concept domain" and "dimension" in a supplement should be consistent with any published scoring instructions or other references. However, if "dimension" appears in the published references, add "(concept domain)" in parentheses to the supplement the first time "dimension" is used so an individual reviewing and familiar with that terminology will understand that the two terms can be used interchangeably (or vice versa, if "concept domain" or "domain" appears in the published references).

...