Identifiers

SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes

#	Variable Name	Variable Label	Type	Role	Usage Restrictions	Variable C-code	Definition	Notes	Examples
1	STUDYID	Study Identifier	Char	Identifier		C83082	A sequence of characters used by the sponsor to uniquely identify the study.
2	DOMAIN	Domain Abbreviation	Char	Identifier		C49558	An 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.
3	USUBJID	Unique Subject Identifier	Char	Identifier		C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4	POOLID	Pool Identifier	Char	Identifier		C117053	A 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.
5	SPDEVID	Sponsor Device Identifier	Char	Identifier		C117060	A sequence of characters used by the sponsor to uniquely identify a specific device.
6	SPTOBID NEW VAR	Applicant-defined Tobacco Product Identifier	Char	Identifier	Tobacco IG only		A sequence of characters used by the applicant to uniquely identify a tobacco product.
7	IGDCMPID NEW VAR	Ingredient or Component Identifier	Char	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	STOCONIDNEW VAR	Applicant-defined Storage Conditions ID	Char	Identifier	PT Domain Only		A sequence of characters used by the applicant to uniquely identify a set of environmental conditions under which a product was stored.		"E-Liquid Standard Long Term Conditions", "Storage Conditions 1"
9	NHOID	Non-Host Organism Identifier	Char	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)"
10	FETUSID	Fetus Identifier	Char	Identifier	Not in human clinical trials	C170497	A sequence of characters used to uniquely identify a fetus associated with a maternal subject, for a particular prenatal evaluation.
11	FOCID	Focus of Study-Specific Interest	Char	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")
12	--SEQ	Sequence Number	Num	Identifier		C70710	A 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.
13	--GRPID	Group ID	Char	Identifier		C170996	A sequence of characters used to uniquely identify related records for a subject within a domain, or related parameters in the TS dataset.	See also Section 5.1.6, Trial Summary Information and Section 5.1.7, Challenge Agent Characterization.
14	--REFID	Reference ID	Char	Identifier		C82531	A 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.
15	--RECID	Invariant Record Identifier	Char	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.
16	--SPID	Sponsor-Defined Identifier TOBA-184 - Getting issue details... STATUS	Char	Identifier		C82530	A sponsor-defined sequence of characters used to identify an instance of an observation.		A preprinted line identifier on a Concomitant Medications form.
17	--LNKID	Link ID	Char	Identifier		C117050	A 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.
18	--LNKGRP	Link Group ID	Char	Identifier		C117049	A 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.
19	--BEATNO	ECG Beat Number	Num	Identifier	EG Domain only			A sequence number that identifies the beat within an ECG.

Metadata Checks Findings

Content: Variable Name SPTOBID NEW VAR is longer than 8 characters
Content: For variable SPTOBID NEW VAR, variable label Applicant-defined Tobacco Product Identifier is longer than 40 characters
Content: Variable Name IGDCMPIDNEW VAR is longer than 8 characters
Content: Variable Name STOCONIDNEW VAR is longer than 8 characters

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