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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
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyTOBA-217
    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.

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