| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
| DOMAIN | Domain Abbreviation | Char | DM | Identifier | Two-character abbreviation for the domain. | Req |
| USUBJID | Unique Subject Identifier | Char |
| Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req |
| SUBJID | Subject Identifier for the Study | Char |
| Topic | Subject (i.e., Animal) identifier used within the study. | Req |
| RFSTDTC | Subject Reference Start Date/Time | Char | ISO 8601 | Record Qualifier | Reference start date/time for the subject in ISO 8601 format. Usually equivalent to date/time when subject was first exposed to study treatment. Study day calculation (the --DY variable) in all domains will be based on this date. The sponsor must define what collected date is used to populate RFSTDTC in the data definition file. | Req |
| RFENDTC | Subject Reference End Date/Time | Char | ISO 8601 | Record Qualifier | Reference end date/time for the subject in ISO 8601 format. Usually equivalent to the date/time when the subject was determined to have left the study. The sponsor must define what collected date is used to populate RFENDTC in the data definition file. | Exp |
| RFXSTDTC | Date/Time of First Study Exposure | Char | ISO 8601 | Record Qualifier | First date/time of exposure to any protocol-specified product exposure, equal to the earliest value of EXSTDTC. Note: Absolute first. | Perm |
| RFXENDTC | Date/Time of Last Study Exposure | Char | ISO 8601 | Record Qualifier | Last date/time of exposure to any protocol-specified product exposure, equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is missing). Note: Absolute last | Perm |
| SITEID | Study Site Identifier | Char |
| Record Qualifier | Unique identifier for a study site within a submission. Use only if subjects are housed at different sites. | Perm |
| BRTHDTC | Date/Time of Birth | Char | ISO 8601 | Record Qualifier | Date/Time of birth of the subject, in ISO 8601 format. | Perm |
| AGE | Age | Num |
| Record Qualifier | May be derived (RFSTDTC – BRTHDTC), but BRTHDTC may not be available in all cases. Age may also be collected. | Perm |
| AGETXT | Age Range | Char | number-number | Record Qualifier | Used when the age is a range and the exact birthdate is not known. This variable is a character field for the purposes of defining age ranges, e.g., if the information available for the age of the subject is 6-8 and AGEU is WEEKS. Populate only when BRTHDTC or AGE is not specified. The format for AGETXT is "number-number" (e.g., 6-8). | Perm |
| AGEU | Age Unit | Char | (AGEU) | Variable Qualifier | Units associated with AGE and AGETXT. | Exp |
| SEX | Sex | Char | (SEX) | Record Qualifier | The sex of the subject. | Req |
| SPECIES | Species | Char | (SPECIES) | Record Qualifier | If this variable is excluded in the DM domain, the information must be present at a higher level (either Trial Sets or Trial Summary). | Perm |
| STRAIN | Strain/Substrain | Char | (STRAIN) | Record Qualifier | Used to identify the vendor-supplied strain, substrain, or breed designation for the test system under study. It may combine the background strain, substrain, and associated genetic modifications as supplied by the vendor (e.g., C57BL/6, A/J, B6.129-Pparg<tm2Rev>/J, FISCHER 344, SPRAGUE-DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, and CHIMPANZEE). The SEND Controlled Terminology codelist consists of commonly used wild type strains. It is extensible to accommodate strains not listed and genetically modified substrains. If this variable is excluded in the DM domain, the information must be present at a higher level (either Trial Sets or Trial Summary). Country of origin for non-human primates should not go into STRAIN. In general, details related to coat color (e.g., White and Red designations for New Zealand Rabbits) should not go into STRAIN. | Perm |
| SBSTRAIN | Strain/Substrain Details | Char |
| Record Qualifier | Free-text field that allows the sponsor to enter further details qualifiying the SPECIES and/or STRAIN, depending on the level to which these variables were defined. Examples include the description of a specific genetic alteration, country of origin for non-human primates, details related to coat color (e.g., White and Red designations for New Zealand Rabbits), and important animal husbandry information (e.g., SPF, BR, VAF). | Perm |
| ARMCD | Planned Arm Code | Char |
| Record Qualifier | Short name for ARM (may be up to 20 characters) used for sorting and programming. Should be populated when Arms have been defined in the TA domain. | Exp |
| ARM | Description of Planned Arm | Char |
| Synonym Qualifier | Descriptive name given to a specific Trial Arm to which the subject was assigned. | Perm |
| SETCD | Set Code | Char |
| Record Qualifier | Short name of a specific Trial Set to which the subject was assigned, as defined by the applicant. Maximum of 8 characters. This represents the Trial Set for which parameters are being submitted. | Req |