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Description


Specification

TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharEXIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier 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
POOLIDPool IdentifierChar
IdentifierIdentifier 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
FOCIDFocus of Study-Specific InterestChar
IdentifierIdentification 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
EXSEQSequence NumberNum
IdentifierThe sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.Req
EXTRTName of Actual ProductChar
TopicName of the product, as defined by the protocol.Req
EXDOSEDose per AdministrationNum
Record QualifierAmount of product administered.Exp
EXDOSTXTDose DescriptionChar
Record QualifierIf 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
EXDOSUDose UnitsChar(UNIT)Variable QualifierUnits for EXDOSE or EXDOSTXT. Examples: ng, mg, or mg/kg.Exp
EXDOSFRMDose FormChar(FRM)Variable QualifierDose form for product (form administered). Examples: TABLET, LOTION.Exp
EXDOSFRQDosing Frequency Per IntervalChar(FREQ)Variable QualifierUsually expressed as the number of repeated administrations of EXDOSE within a specific time period. Examples: QD (once daily), BID (2x daily).Req
EXROUTERoute of AdministrationChar(ROUTE)Variable QualifierRoute of administration for EXTRT. Examples: ORAL GAVAGE, DERMAL, INTRAVENOUS.Req
EXLOTLot NumberChar
Record QualifierLot 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
EXLOCLocation of Dose AdministrationChar
Record QualifierSpecifies 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
EXMETHODMethod of AdministrationChar
Record QualifierMethod of the dose administration. Example: INFUSION.Perm
EXTRTVProduct VehicleChar
Record QualifierDescribes vehicle used for exposure. Example: SALINE.Exp
EXVAMTAmount AdministeredNum
Record QualifierThe 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
EXVAMTUAmount Administered UnitsChar(UNIT)Variable QualifierUnits for EXVAMT (per dose administration).Perm
EXADJReason for Dose AdjustmentChar
Record QualifierDescribes 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
EXSTDTCStart Date/Time of ExposureCharISO 8601 datetime or intervalTimingDate/Time when administration of the product indicated by EXTRT and EXDOSE began, in ISO 8601 format.Exp
EXENDTCEnd Date/Time of ExposureCharISO 8601 datetime or intervalTimingDate/Time when administration of the product indicated by EXTRT and EXDOSE ended, in ISO 8601 format.Perm
EXSTDYStudy Day of Start of ExposureNum
TimingStudy day when administration of the product began, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain.Perm
EXENDYStudy Day of End of ExposureNum
TimingStudy day when administration of the product ended, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain.Perm
EXDURDuration of ExposureCharISO 8601 durationTimingDuration and unit of time for a continuous exposure. This may be used to denote the length of an infusion (e.g., PT10M to indicate 10 minutes).Perm
EXTPTPlanned Time Point NameChar
TimingText 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
EXTPTNUMPlanned Time Point NumberNum
TimingNumerical version of EXTPT to aid in sorting.Perm
EXELTMPlanned Elapsed Time from Time Point RefCharISO 8601 durationTimingPlanned 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
EXTPTREFTime Point ReferenceChar
TimingName 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
EXRFTDTCDate/Time of Reference Time PointCharISO 8601 datetime or intervalTimingDate/Time of the reference time point, EXTPTREF.Perm


Assumptions

  1. Definition:
    1. The Exposure (EX) domain model records the details of a subject's administered dose of protocol-specified study product. "Study product" may be any intervention that is prospectively defined as a test material within a study, and is typically, but not always, administered to the subject. Examples include but are not limited to placebo, active comparators, and investigational products. Only protocol-specified products should be included in this domain.
    2. This domain should contain 1 record per constant dosing interval per subject per administration site (as identified in FOCID). A constant dosing interval is applicant-defined and represents a specific period of time during which a subject was exposed with a specific lot at a constant dose level. For example, for a study with once-a-week administration of a standard dose for 6 weeks, the administered dose may be represented with a single record per subject, spanning the entire dosing phase. Alternatively, a separate entry can be made for each dose administration and for any deviations in dosing that occur. For this example, there could be up to 6 records (1 for each weekly administration).
    3. Either USUBJID or POOLID must be populated.
  2. Exposure Product Description:
    1. EXTRT captures the name of the protocol-specified study product and is the topic variable. It is a Required variable and must have a value. EXTRT must include only the product name and must not include dosage, formulation, or other qualifying information. For example, "4mg Nicotine Lozenge" is not a valid value for EXTRT. This example should be expressed as EXTRT = "Nicotine", EXDOSE = "4", EXDOSU = "mg", and EXDOSFRM = "LOZENGE".
    2. A single control for multiple compounds should contain values separated with a pipe/vertical bar (|).
  3. If a subject is exposed sequentially with different lots, then a new record must be created for each lot number given.
  4. EXDOSE: The applicant's data definition file should indicate whether the values in EXDOSE represent intended or actual dose levels.
  5. Timing variables: The timing of dosing of study product is captured by the start/end date and start/end time of each constant-dosing interval. The applicant defines the dosing interval.
  6. Other additional qualifiers from the SDTM Interventions class may be added to this domain.

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