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This is the SDTM dataset associated with the above example CRF. This SDTM dataset used CMENRF to represent ongoing interventions. More information can be found in SDTMIG Section 4.4.7, Use of Relative Timing Variables.
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Rows 1-6: | The subject reported each instance of aspirin use. The frequency in each record is (CMDOSFRQ) is "ONCE". | Rows 7-9: | The subject reports the use of 3 medications. Diovan and Zoloft were still being taken by the subject, Astelin was a nasal spray where 2 sprays were taken twice be day. in each nostril. Note that only partial start dates are provided for Diovan and Zoloft. | Row 10: | The subject took aspirin with a frequency of "PRN". This approach assumes that knowing exactly when aspirin was used is not important for evaluating safety and efficacy in this study. | |
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Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMDOSE | CMDOSTXT | CMDOSU | CMDOSFRM | CMDOSFRQ | CMROUTE | CMSTDTC | CMENDTC | CMENRF |
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1 | ABC | CM | ABC-0001 | 1 | ASPIRIN | 100 |
| mg | TABLET | ONCE | ORAL | 2004-01-01 | 2004-01-01 |
| 2 | ABC | CM | ABC-0001 | 2 | ASPIRIN | 100 |
| mg | TABLET | ONCE | ORAL | 2004-01-02 | 2004-01-02 |
| 3 | ABC | CM | ABC-0001 | 3 | ASPIRIN | 100 |
| mg | TABLET | ONCE | ORAL | 2004-01-03 | 2004-01-03 |
| 4 | ABC | CM | ABC-0001 | 4 | ASPIRIN | 100 |
| mg | TABLET | ONCE | ORAL | 2004-01-07 | 2004-01-07 |
| 5 | ABC | CM | ABC-0001 | 5 | ASPIRIN | 100 |
| mg | TABLET | ONCE | ORAL | 2004-01-07 | 2004-01-07 |
| 6 | ABC | CM | ABC-0001 | 6 | ASPIRIN | 100 |
| mg | TABLET | ONCE | ORAL | 2004-01-09 | 2004-01-09 |
| 7 | ABC | CM | ABC-0002 | 1 | DIOVAN | 20 |
| mg | TABLET | BID | ORAL | 2004 |
| AFTER | 8 | ABC | CM | ABC-0002 | 2 | ZOLOFT | 50 |
| mg | TABLET | OD | ORAL | 2004-01 |
| AFTER | 9 | ABC | CM | ABC-0002 | 3 | ASTELIN |
| 2 sprays in each nostril -137 mcg | mcg | SPRAY | BID | NASAL | 2004-01-09 | 2004-06-10 |
| 10 | ABC | CM | ABC-0003 | 1 | ASPIRIN | 100 |
| mg | TABLET | PRN | ORAL | 2004-01-01 |
| AFTER | |
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