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Shareqc_sdtm21_ds
PurposeIdentifiers
#Variable NameVariable LabelTypeFormatRoleVariable(s) QualifiedUsage RestrictionsVariable C-codeDefinitionNotesExamples
1STUDYIDStudy IdentifierChar
Identifier

C83082A sequence of characters used by the sponsor to uniquely identify the study.

2
GNTXAIDGenetic Toxicology Assay IdentifierCharIdentifierTobacco Implementation Guide Only

Status
colourRed
titleNEW
A short sequence of characters that uniquely identifies a genetic toxicology assay within a study.

MNVIT, MLA3
DOMAINDomain AbbreviationChar
Identifier

C49558An abbreviation for a collection of observations, with a topic-specific commonality.2-character abbreviation. The domain abbreviation is also used as a prefix for variables to ensure uniqueness when datasets are merged.
4

3USUBJIDUnique Subject IdentifierChar
Identifier

C69256A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.
5



4POOLIDPool IdentifierChar
Identifier

C117053A sequence of characters used to uniquely identify a group of subjects that have been pooled together.Used for results that are not assignable to a specific subject.
6

5SPDEVIDSponsor Device IdentifierChar
Identifier

C117060A sequence of characters used by the sponsor to uniquely identify a specific device.
7SDTM-714


6

SPTOBID

Sponsor

Status
colourRed
titleNEW VAR

Applicant-Defined Tobacco Product

Identifier
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key

ID

Char
Identifier

Tobacco

Implementation Guide Only

IG only


A sequence of characters used by the applicant to uniquely identify a tobacco product.



7

IGDCMPID

Status
colourRed
titleNEW VAR

Ingredient or Component IdentifierChar
Identifier
PT Domain Only
A sequence of characters used by the applicant to uniquely identify an ingredient, substance or component of a tobacco product.

"Burley Tobacco", "Cellulose Pulp"

8

STOCONID

Status
colourRed
titleNEW VAR

Applicant-defined Storage Conditions ID

Char
Identifier
PT Domain Only

A sequence of characters used by the

sponsor

applicant to uniquely identify a set of environmental conditions under which a

tobacco

product was stored.


"E-Liquid Standard Long Term Conditions", "Storage Conditions 1"

9
8

NHOID

Non-Host Organism IdentifierChar
Identifier



Sponsor-defined identifier for a non-host organism. This variable should be populated with an intuitive name based on the identity of the non-host organism as reported by the lab.

"A/California/7/2009 (H1N1)"

9
10FETUSIDFetus IdentifierChar
Identifier
Not in human clinical trialsC170497A sequence of characters used to uniquely identify a fetus associated with a maternal subject, for a particular prenatal evaluation.
10


11FOCIDFocus of Study-Specific InterestChar
Identifier



Identification of a focus of study-specific interest on or within a subject or specimen as called out in the protocol for which a measurement, test, or examination was performed. The value in this variable should have inherent semantic meaning.

A drug application site (e.g., "Injection site 1", "Biopsy site 1", "Treated site 1"), or a more specific focus (e.g., "OD" (right eye), "Upper left quadrant of the back")
11
12--SEQSequence NumberNum
Identifier

C70710A number used in combination with the identifier of the subject of the observation to uniquely identify a record within a domain.

May be any valid number (including decimals) and does not have to start at 1. Datasets that do not contain subject data, such as the Trial Summary (TS) domain and the Device Tracking (DT) domains, use --SEQ as a sequence number to ensure uniqueness within the dataset.

12

13--GRPIDGroup IDChar
Identifier

C170996A sequence of characters used to uniquely identify related records for a subject within a domain, or related parameters in the
Trial Summary (
TS
)
dataset.See also Section 5.1.6, Trial Summary Information and Section 5.1.7, Challenge Agent Characterization.
13

14--REFIDReference IDChar
Identifier

C82531A sequence of characters used to uniquely identify a source of information.
A lab specimen ID, the UUID for an ECG waveform or a medical image.
14
15--RECIDInvariant Record IdentifierChar
Identifier



Identifier for a record that is unique within a domain for a study and that remains invariant through subsequent versions of the dataset, even if the content of the record is modified. When a record is deleted, this value must not be reused to identify another record in either the current or future versions of the domain.

15

16--SPID

Sponsor-Defined Identifier

Char
Identifier

C82530A sponsor-defined sequence of characters used to identify an instance of an observation.
A preprinted line identifier on a Concomitant Medications form.
16
17--LNKIDLink IDChar
Identifier

C117050A sequence of characters used to uniquely identify a record, for a subject, in one domain and link it to 1 or more records for that subject in another domain.This may be a one-to-one or a one-to-many relationship.A value that links a single tumor to multiple measurements/assessments performed at different times.
17
18--LNKGRPLink Group IDChar
Identifier

C117049A sequence of characters used to uniquely identify a group of records, for a subject, in one domain and link it to 1 or more records for that subject in another domain.This will usually be a many-to-one relationship.A value that links multiple tumor measurement/assessments to a single response to therapy.
18
19--BEATNOECG Beat NumberNum
Identifier
EG Domain only

A sequence number that identifies the beat within an ECG.