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TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

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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

SV

Identifier

Two-character abbreviation for the domain most relevant to the observation. The domain abbreviation is also used as a prefix for variables to ensure uniqueness when datasets are merged.

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

VISITNUM

Visit Number

Num


Topic

Clinical encounter number. Numeric version of VISIT, used for sorting.

Req

VISIT

Visit Name

Char


Synonym Qualifier

Protocol-defined description of a clinical encounter.

Perm

SVPRESP

Pre-specified

Char

(NY)

Variable Qualifier

Used to indicate whether the visit was planned (i.e., visits specified in the TV domain). Value is "Y" for planned visits, null for unplanned visits.

Exp

SVOCCUR

Occurrence

Char

(NY)

Record Qualifier

Used to record whether a planned visit occurred. The value is null for unplanned visits.

Exp

SVREASOC

Reason for Occur Value

Char


Record Qualifier

The reason for the value in SVOCCUR. If SVOCCUR="N", SVREASOC is the reason the visit did not occur.

Perm

SVCNTMOD

Contact Mode

Char

(CNTMODE)

Record Qualifier

The way in which the visit was conducted. Examples: "IN PERSON", "TELEPHONE CALL", "IVRS".

Perm

SVEPCHGI

Epi/Pandemic Related Change Indicator

Char

(NY)

Record Qualifier

Indicates whether the visit was changed due to an epidemic or pandemic.

Perm

VISITDY

Planned Study Day of Visit

Num


Timing

Planned study day of VISIT. Should be an integer.

Perm

SVSTDTC

Start Date/Time of Observation

Char

ISO 8601 datetime or interval

Timing

Start date/time of an observation represented in IS0 8601 character format.

Exp

SVENDTC

End Date/Time of Observation

Char

ISO 8601 datetime or interval

Timing

End date/time of the observation represented in IS0 8601 character format.

Exp

SVSTDY

Study Day of Start of Observation

Num


Timing

Actual study day of start of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.

Perm

SVENDY

Study Day of End of Observation

Num


Timing

Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.

Perm

SVUPDES

Description of Unplanned Visit

Char


Record Qualifier

Description of what happened to the subject during an unplanned visit. Only populated for unplanned visits.

Perm

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