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  1. The animal number given in this study is the SUBJID. In this example, STUDYID and SUBJID have been concatenated to create the USUBJID. This is to ensure that this particular animal is referred to in a unique way throughout an entire submission, which one might expect to be composed of several studies where each study contains an animal number with SUBJID = "1." Note: USUBJID does not need necessarily to be created by concatenating STUDYID and SUBJID, but it must be a unique identifying value for a subject across all studies within the submission.
  2. This is a simple study where ARMCD represents dose groups, which is not always the case. This study has 3 groups (ARMCD values 1-3): ARMCD = "1" is the control animals, ARMCD = "2" is the low-dose animals, and ARMCD = "3" is the high-dose animals.
  3. The actual birth dates of the animals were recorded; therefore, the age of the animals was calculated and recorded.
  4. In this example, the variable "SPECIES" has been omitted because this information is within the Trial Summary (TS) domain.

Rows 1-6: Show demographics records for 6 subjects. Note that the subjects possess birthdates (BRTHDTC) and ages (AGE, AGEU).

dm.xpt

dm.xpt

RowSTUDYIDDOMAINUSUBJIDSUBJIDRFSTDTCRFENDTCBRTHDTCAGEAGEUSEXARMCDARMSETCD
1ABCDMABC-112006-01-012006-03-102005-12-0131DAYSM1Control1
2ABCDMABC-222006-01-012006-02-282005-12-0131DAYSM1Control1
3ABCDMABC-332006-01-012006-03-192005-12-0131DAYSM2Low2
4ABCDMABC-442006-01-012006-03-102005-12-0131DAYSF2Low2
5ABCDMABC-552006-01-012006-03-312005-12-1517DAYSF3High3
6ABCDMABC-662006-01-012006-04-052005-12-1616DAYSF3High3
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