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- Conforms to Study Data Tabulation Model Metadata Submission Guidelines (SDTM-MSG) annotated examples. Should be a space before and after each "=" sign
- Majority of items don't have space before and after each "=" sign
- 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.
- --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.
- (out of date! evaluator will only be a suppqual now) 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.
- Conforms to Study Data Tabulation Model Metadata Submission Guidelines (SDTM-MSG) annotated examples. Should be a space before and after each "=" sign
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