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 the section Section 2.8.7.6, Representing References and Relative Timing.
The sponsor include applicant included CMDECOD. The sponsor is applicant is required to provide the dictionary name and version in the Define-XML document.
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| Rows 1-4: | The subject reported each instance of aspirin use. The frequency of each instance is represented in CMDOSFRQ and is ONCE. | | Rows 6-8: | 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 a day in each nostril. Note that only partial start dates are provided for Diovan and Zoloft. | | Row 9: | 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 the product in this study. | |
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| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMDECOD | CMINDC | CMCLAS | CMDOSE | CMDOSTXT | CMDOSU | CMDOSFRM | CMDOSFRQ | CMROUTE | CMSTDTC | CMENDTC | CMENRF |
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| 1 | ABC123 | CM | ABC123-0001 | 1 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL | 2006-10-14 | 2006-10-14 |
| | 2 | ABC123 | CM | ABC123-0001 | 2 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL | 2006-10-15 | 2006-10-15 |
| | 3 | ABC123 | CM | ABC123-0001 | 3 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL | 2006-10-16 | 2006-10-16 |
| | 4 | ABC123 | CM | ABC123-0001 | 4 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL | 2006-10-17 | 2006-10-17 |
| | 5 | ABC123 | CM | ABC123-0001 | 5 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL | 2006-01-18 | 2006-01-18 |
| | 6 | ABC123 | CM | ABC123-0002 | 1 | DIOVAN | valsartan | HYPERTENSION | ANTIHYPERTENSIVES | 20 |
| mg | TABLET | BID | ORAL | 2004 |
| AFTER | | 7 | ABC123 | CM | ABC123-0002 | 2 | ZOLOFT | sertraline | PANIC ATTACKS | PSYCHOANALEPTICS | 50 |
| mg | TABLET | OD | ORAL | 2004-01 |
| AFTER | | 8 | ABC123 | CM | ABC123-0002 | 3 | ASTELIN | azelastine | INFLUENZA | NASAL PREPARATIONS |
| 2 sprays in each nostril-137 mcg | mcg | SPRAY | BID | NASAL | 2006-02-26 |
| AFTER | | 9 | ABC123 | CM | ABC123-0002 | 4 | ASPIRIN | acetylsalicylic acid | PAIN | ANALGESICS | 100 |
| mg | TABLET | PRN | ORAL | 2004-01-01 |
| AFTER |
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