| 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 TreatmentProduct | Char |
| Topic | Name of the treatmentproduct, as defined by the protocol. | Req |
| EXDOSE | Dose per Administration | Num |
| Record Qualifier | Amount of treatment product administered. | Exp |
| EXDOSTXT | Dose Description | Char |
| Record Qualifier | If the amount of treatment product administered cannot be represented as a number and populated in EXDOSE, this field is used to describe the amount of treatment 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 treatment 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 | Treatment Product Vehicle | Char |
| Record Qualifier | Describes vehicle used for treatmentexposure. Example: SALINE. | Exp |
| EXVAMT | Amount Administered | Num |
| Record Qualifier | The amount (volume or weight) of the treatment compound 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 – used only when an adjustment is represented in EX. May be used for variations from protocol-specified doses or changes from expected doses (e.g., when dose is adjusted due to toxicity). | Perm |
| EXSTDTC | Start Date/Time of TreatmentExposure | Char | ISO 8601 | Timing | Date/Time when administration of the treatment product indicated by EXTRT and EXDOSE began, in ISO 8601 format. | Exp |
| EXENDTC | End Date/Time of TreatmentExposure | Char | ISO 8601 | Timing | Date/Time when administration of the treatment product indicated by EXTRT and EXDOSE ended, in ISO 8601 format. | Perm |
| EXSTDY | Study Day of Start of TreatmentExposure | Num |
| Timing | Study day when administration of the treatment product began, in integer days. The algorithm for calculations must be relative to the sponsorapplicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
| EXENDY | Study Day of End of TreatmentExposure | Num |
| Timing | Study day when administration of the treatment product ended, in integer days. The algorithm for calculations must be relative to the sponsorapplicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
| EXDUR | Duration of TreatmentExposure | Char | ISO 8601 | Timing | Duration and unit of time for a continuous treatmentexposure. This may be used to denote the length of an infusion (e.g., PT10M to indicate 10 minutes). | Perm |
| EXTPT | Planned Time Point Name | Char |
| Timing | Text description of time when a dose should be given. Note: This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See EXTPTNUM and EXTPTREF. | Perm |
| EXTPTNUM | Planned Time Point Number | Num |
| Timing | Numerical version of EXTPT to aid in sorting. | Perm |
| EXELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 | Timing | Planned elapsed time (in ISO 8601 format) relative to the planned fixed reference (EXTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "- PT15M" to represent the period of 15 minutes prior to the reference point indicated by EXTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by EXTPTREF. | Perm |
| EXTPTREF | Time Point Reference | Char |
| Timing | Name of the fixed reference point referred to by EXELTM, if used for EXTPTNUM, and EXTPT. It is recommended that EXTPTREF be as descriptive as possible so the reference time point can be inferred without looking at other variables. Examples: Previous dose, previous feed. | Perm |
| EXRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 | Timing | Date/Time of the reference time point, EXTPTREF. | Perm |