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NEED TO GET THE CORRECT REFERNCES More information can be found in SDTMIG Section 4.4.7, Use of Relative Timing Variables. |
This is an example CRF used to collect general concomitant medications in a study. This CRF was designed to allow the sponsor to use either CMENRF or CMENRTPT to represent an intervention was ongoing.
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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 in Section 42.48.7, Use of Relative Timing Variables.6, Representing References and Relative Timing.
The applicant included CMDECOD. The applicant is required to provide the dictionary name and version in the Define-XML document.
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| Rows 1-64: | The subject reported each instance of aspirin use. The frequency of each instance is represented in CMDOSFRQ and is ONCE. | | Rows 76-98: | 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 109: | 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 |
ABCABC| ABC123-0001 | 1 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL |
2004010120040101ABCABC| ABC123-0001 | 2 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL |
2004010220040102ABCABC| ABC123-0001 | 3 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL |
2004010320040103ABCABC| ABC123-0001 | 4 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL |
2004010720040107ABCABC100mg | TABLET | ONCE | ORAL | 2004-01-07 | 2004-01-07 | 6 | ABC | CM | ABC-0001 | 6 | ASPIRIN2004092004097ABCABC| ABC123-0002 | 1 | DIOVAN | valsartan | HYPERTENSION | ANTIHYPERTENSIVES | 20 |
| mg | TABLET | BID | ORAL | 2004 |
| AFTER |
8ABCABC| ABC123-0002 | 2 | ZOLOFT | sertraline | PANIC ATTACKS | PSYCHOANALEPTICS | 50 |
| mg | TABLET | OD | ORAL | 2004-01 |
| AFTER |
9ABCABC| ABC123-0002 | 3 | ASTELIN | azelastine | INFLUENZA | NASAL PREPARATIONS |
| 2 sprays in each nostril-137 mcg | mcg | SPRAY | BID | NASAL |
200401092004-06-10 | 10 | ABCABC00031| 4 | ASPIRIN | acetylsalicylic acid | PAIN | ANALGESICS | 100 |
| mg | TABLET | PRN | ORAL | 2004-01-01 |
| AFTER |
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