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Metadataspec

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Shareqc_send4tig10_ds

Class	Interventions
Domain	EX

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Variable Name	Variable Label	Type

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Controlled Terms, Codelist, or Format	Role	CDISC Notes	Core
STUDYID	Study Identifier	Char

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		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

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	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

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		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

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	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

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		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

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Product

Char

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Topic

Name of the

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product, as defined by the protocol.	Req
EXDOSE	Dose per Administration	Num

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Record Qualifier

Amount of

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product administered.	Exp
EXDOSTXT	Dose Description	Char

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Record Qualifier

If the amount of

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product administered cannot be represented as a number and populated in EXDOSE, this field is used to describe the amount of

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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

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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

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		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

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		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

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	Record Qualifier	Method of the dose administration. Example: INFUSION.	Perm
EXTRTV

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Product Vehicle

Char

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Record Qualifier

Describes vehicle used for

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exposure. Example: SALINE.	Exp
EXVAMT	Amount Administered	Num

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Record Qualifier

The amount (volume or weight) of the

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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

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Record Qualifier

Describes reason or explanation of why a dose is adjusted

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- 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.,

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when dose is adjusted due to toxicity).	Perm
EXSTDTC	Start Date/Time of

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Exposure

Char

ISO 8601 datetime or interval

Timing

Date/Time when administration of the

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product indicated by EXTRT and EXDOSE began, in ISO 8601 format.	Exp
EXENDTC	End Date/Time of

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Exposure

Char

ISO 8601 datetime or interval

Timing

Date/Time when administration of the

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product indicated by EXTRT and EXDOSE ended, in ISO 8601 format.	Perm
EXSTDY	Study Day of Start of

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Exposure

Num

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Timing

Study day when administration of the

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product began, in integer days. The algorithm for calculations must be relative to the

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applicant-defined RFSTDTC variable in the Demographics (DM) domain.	Perm
EXENDY	Study Day of End of

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Exposure

Num

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Timing

Study day when administration of the

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product ended, in integer days. The algorithm for calculations must be relative to the

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applicant-defined RFSTDTC variable in the Demographics (DM) domain.	Perm
EXDUR	Duration of

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Exposure

Char

ISO 8601 duration

Timing

Duration and unit of time for a continuous

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exposure. 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

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		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

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		Timing	Numerical version of EXTPT to aid in sorting.	Perm
EXELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601 duration	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

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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

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		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 datetime or interval	Timing	Date/Time of the reference time point, EXTPTREF.	Perm

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