| 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 | EX | 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. Either USUBJID or POOLID must be populated. | Exp |
| POOLID | Pool Identifier | Char |
| Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm |
| FOCID | Focus of Study-Specific Interest | Char |
| Identifier | Identification of a focus of study-specific interest on or within a subject or specimen as defined in the protocol for which a measurement, test, or examination was performed, such as a drug application site, e.g., "Injection site 1," "Biopsy site 1," "Treated site 1." the value in this variable should have inherent semantic value. | Perm |
| EXSEQ | Sequence Number | Num |
| Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req |
| EXTRT | Name of Actual Product | Char |
| Topic | Name of the product, as defined by the protocol. | Req |
| EXDOSE | Dose per Administration | Num |
| Record Qualifier | Amount of product administered. | Exp |
| EXDOSTXT | Dose Description | Char |
| Record Qualifier | If the amount of product administered cannot be represented as a number and populated in EXDOSE, this field is used to describe the amount of product administered. Example: 200-400. | Perm |
| EXDOSU | Dose Units | Char | (UNIT) | Variable Qualifier | Units for EXDOSE or EXDOSTXT. Examples: ng, mg, or mg/kg. | Exp |
| EXDOSFRM | Dose Form | Char | (FRM) | Variable Qualifier | Dose form for product (form administered). Examples: TABLET, LOTION. | Exp |
| EXDOSFRQ | Dosing Frequency Per Interval | Char | (FREQ) | Variable Qualifier | Usually expressed as the number of repeated administrations of EXDOSE within a specific time period. Examples: QD (once daily), BID (2x daily). | Req |
| EXROUTE | Route of Administration | Char | (ROUTE) | Variable Qualifier | Route of administration for EXTRT. Examples: ORAL GAVAGE, DERMAL, INTRAVENOUS. | Req |
| EXLOT | Lot Number | Char |
| Record Qualifier | Lot Number(s) or Batch Number(s) of the EXTRT test article. If mixed lots of the test article are administered during the same constant dosing interval, this should be represented as "Lot A;Lot B." Mixed lots are produced by the mixing of Lots a and B of the test article into one solution, suspension, or dietary food concentration. If no test article was administered, EXLOT should be null. | Exp |
| EXLOC | Location of Dose Administration | Char |
| Record Qualifier | Specifies anatomical location (site) of administration. Example: LEFT HINDLIMB for a topical application or an injection site number. Each administration will require its own record. | Perm |
| EXMETHOD | Method of Administration | Char |
| Record Qualifier | Method of the dose administration. Example: INFUSION. | Perm |
| EXTRTV | Product Vehicle | Char |
| Record Qualifier | Describes vehicle used for exposure. Example: SALINE. | Exp |
| EXVAMT | Amount Administered | Num |
| Record Qualifier | The amount (volume or weight) of the product plus vehicle administered in a single dose. This is not to be confused with EXDOSE. EXDOSE refers to the amount of test material administered to the subject. | Perm |
| EXVAMTU | Amount Administered Units | Char | (UNIT) | Variable Qualifier | Units for EXVAMT (per dose administration). | Perm |
| EXADJ | Reason for Dose Adjustment | Char |
| Record Qualifier | Describes reason or explanation of why a dose is adjusted |