The following examples illustrate typical scenarios in the DM domain. Example 1 is a general DM example showing a study of 6 animals with different arms recorded.
Example: General Demographics
- 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 TOBA-217 - Getting issue details... STATUS STUDYID and SUBJID, but it must be a unique identifying value for a subject across all studies within the submission.
- 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.
- The actual birth dates of the animals were recorded; therefore, the age of the animals was calculated and recorded.
In this example, the variable "SPECIES" has been omitted because this information is within the Trial Summary (TS) domain.
Example: Unknown Birth Date
In this example, the exact birth date of the animal is not known, but there is an age range, so the AGETXT in conjunction with the AGEU is used. This study has some animals where the sex of the animals is either unknown or undifferentiated.
TOBA-218 - Getting issue details... STATUS
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Example: Species, Strains, and Substrains
TOBA-219
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STATUS
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