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| Dataset2 |
|---|
Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSLNKID | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSSTRESC | VSSTRESN | VSSTRESU | VSLOC | VSBLFL | VISITNUM | VSDTC |
|---|
| 1 | STUDYX | VS | P0001 | 1 | AP01 | TEMP | Temperature | 38.9 | C | 38.9 | 38.9 | C | RECTUM | Y | 1 | 2014-06-24 | | 2 | STUDYX | VS | P0001 | 2 | AP02 | MAP | Mean Arterial Pressure | 117 | mmHg | 117 | 117 | mmHg |
| Y | 1 | 2014-06-24 | | 3 | STUDYX | VS | P0001 | 3 | AP03 | HR | Heart Rate | 98 | beats/min | 98 | 98 | beats/min |
| Y | 1 | 2014-06-24 | | 4 | STUDYX | VS | P0001 | 4 | AP04 | RESP | Respiratory Rate | 54 | breaths/min | 54 | 54 | breaths/min |
| Y | 1 | 2014-06-24 |
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| Rowcaps |
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| Rows 1-4: | Represent diabetes and rheumatoid arthritis medical history used to calculate the risk scores for subject 1001-001 shown in the RS domain above. |
| Rows 5-6: | Represent diabetes and rheumatoid arthritis medical history used to calculate the risk score for subject 1001-002 shown in the RS domain above. |
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| Rowcaps |
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| Rows 1-2: | Represent smoking information used to calculate the risk scores for subject 1001-001 shown in the RS domain above. | | Row 3: | Represents smoking information used to calculate the risk score for subject1001-002 shown in the RS domain above. |
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| Dataset2 |
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| | Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SULNKID | SUTRT | SUCAT | SUDOSE | SUDOSU | SUDOSFQ | SUSTRTPT | SUSTTPT | SUENRTPT | SUENTPT | SUPRESP | SUOCCUR | VISITNUM | VISIT | SUDTC |
|---|
| 1 | 1001 | SU | 1001-001 | 1 | 1 | CIGARETTES | TOBACCO | 0 | CIGARETTE | PER DAY |
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| Y | N | 1 | VISIT 1 | 2012-05-10 | | 2 | 1001 | SU | 1001-001 | 2 | 2 | CIGARETTES | TOBACCO | 5 | CIGARETTE | PER DAY | BEFORE | 2012-10-08 | ONGOING | 2012-10-08 | Y | Y | 5 | VISIT 5 | 2012-10-08 | | 3 | 1001 | SU | 1001-002 | 1 | 1 | CIGARETTES | TOBACCO | 20 | CIGARETTE | PER DAY | BEFORE | 2012-04-30 | ONGOING | 2012-04-30 | Y | Y | 1 | VISIT 1 | |
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| Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
|---|
1 | 1001 | RS |
| RSLNKID |
| ONE | A | 2 | 1001 | LB |
| LBLNKID |
| MANY | A | 3 | 1001 | RS |
| RSLNKID |
| ONE | B | 4 | 1001 | VS |
| VSLNKID |
| ONE | B | 5 | 1001 | RS |
| RSLNKID |
| ONE | C | 6 | 1001 | SU |
| SULNKID |
| ONE | C | 7 | 1001 | RS |
| RSLNKID |
| ONE | D | 8 | 1001 | MH |
| MHLNKID |
| MANY | D | 9 | 1001 | RS |
| RSLNKID |
| ONE | E | 10 | 1001 | APMH |
| MHLNKID |
| MANY | |
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4 SDTM Mapping Strategy
This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, RSSTRESN, and RSORRESU) should be populated.
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