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Clinical signs with time points for post-dose periods |
This example shows clinical signs captured in the collection system using categorization. CLTESTCD and CLTEST are simply "Clinical Signs" for all entries in this example. Time points are included to indicate the signs that were taken for post-dose periods.
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Rows 1-6: | CLCAT is used to categorize the clinical signs into a controlled list. | Rows 1-6: | CLTPT is used to specify the observation session in which the observations were collected. CLELTM was not included because this session was not specified in terms of elapsed time after dosing. | Row 6: | CLUSCHFL is used to specify that the observation was unscheduled. Note that CLNOMDY was populated with the actual study day for tabulation. CLNOMLBL reflects the label that was used in the study report. | |
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Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLUSCHFL | CLDTC | CLDY | CLNOMDY | CLNOMLBL | CLTPT | CLTPTNUM |
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1 | ABC1 | CL | ABC1-1001 | 1 | CS | Clinical Signs | CLINICAL SIGNS | Skin, Red | Skin, Red | Pinna, Left |
| 2004-07-19T07:21:39 | 7 | 7 | Day 7 | Postdose 1 | 1 | 2 | ABC1 | CL | ABC1-1001 | 2 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover | Fur, Thin Cover | Hindpaw, Left |
| 2004-07-19T07:16:57 | 7 | 7 | Day 7 | Postdose 1 | 1 | 3 | ABC1 | CL | ABC1-1002 | 1 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover | Fur, Thin Cover | Hindpaw, Right |
| 2004-07-19T07:27:01 | 7 | 7 | Day 7 | Postdose 1 | 1 | 4 | ABC1 | CL | ABC1-1001 | 3 | CS | Clinical Signs | CLINICAL SIGNS | Skin, Red | Skin, Red | Pinna, Left |
| 2004-07-19T02:21:39 | 7 | 7 | Day 7 | Postdose 2 | 2 | 5 | ABC1 | CL | ABC1-1001 | 4 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover | Fur, Thin Cover | Hindpaw, Left |
| 2004-07-19T02:16:57 | 7 | 7 | Day 7 | Postdose 2 | 2 | 6 | ABC1 | CL | ABC1-1002 | 2 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover | Fur, Thin Cover | Hindpaw, Right | Y | 2004-07-19T04:15:01 | 7 | 7 | Day 7 Unscheduled |
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