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• •  Conforms to Study Data Tabulation Model Metadata Submission Guidelines (SDTM-MSG) annotated examples.
  •  Per the Metadata example, Domain abbreviation = "Domain Name" (e.g., QS=Questionnaires) appears at the top of the page in Arial 18 point font, black color, bolded, and italicized. It is enclosed in a black 1 point thickness text box with a light blue fill color.
  •  --CAT = QRS Short Name appears at the top of the page in Arial 12 point font, red color, bold, italicized, enclosed in a black 1 point thickness text box with a light blue fill color.  
  •  Variable annotations are in Arial 10 or 12 point font, red color, bold, and italicized. They are enclosed in a black 1 point thickness text box with a light blue fill color. Be consistent within a page and use 12 point unless space is an issue and then use 10 pt.
    •  N/A
  •  --ORRES, --STRESC and --STRESN are annotated if these results are clearly identified on the CRF. Repetition of these annotations may be eliminated if it clearly identifies these variables are repeated on subsequent questions.
  •  EVAL is only annotated on the CRF when clearly identified on the CRF.
    •  --EVAL is not listed on the CRF.
  •  QNAM is annotated on the CRF for supplemental qualifier variables.
    •  No QNAMs are used in the supplement.
  •  Copyright or Public domain CDISC text box is on the CRF.
  •  For CDISC-created QRS instrument CRFs, the instrument's reference article needs to be included as a footnote on the annotated CRF.

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