For information on the naming of supplemental qualifier datasets, see the SDTMIG, SDTMIG-AP, SENDIG, and TIG.

SUPP-- Dataset

SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 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 LabelTypeFormatRoleVariable(s) QualifiedUsage RestrictionsVariable C-codeDefinitionNotesExamples
1STUDYIDStudy IdentifierChar
Identifier

C83082

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



2RDOMAINRelated Domain AbbreviationChar
Identifier



2-character abbreviation for the domain of the parent record(s).
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.

4APIDAssociated Persons IdentifierChar
Identifier



Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person (see Section 6.3, Pool Definition Dataset, and Section 4, Associated Persons Data).
5POOLIDPool IdentifierChar
Identifier


A sequence of characters used to uniquely identify a group of subjects that have been pooled together.



6SPDEVIDSponsor Device IdentifierChar
Identifier

C117060A sequence of characters used by the sponsor to uniquely identify a specific device.

7IDVARIdentifying VariableChar
Identifier



Identifying variable in the parent dataset that identifies the related record(s).--SEQ, --GRPID
8IDVARVALIdentifying Variable ValueChar
Identifier



Value of identifying variable of the parent record(s).
9QNAMQualifier Variable NameChar
Topic



The short name of the qualifier variable, which is used as a column name in a domain view with data from the parent domain. The value in QNAM cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST").

QNAM cannot contain characters other than letters, numbers, or underscores. This will often be the column name in the sponsor's operational dataset. QNAM should not be the name of any standard ADaM variable.


10QLABELQualifier Variable LabelChar
Synonym QualifierQNAM


This is the long name or label associated with QNAM. The value in QLABEL cannot be longer than 40 characters. This will often be the column label in the sponsor's original dataset.
11QVALData ValueChar
Result Qualifier



Result of, response to, or value associated with QNAM. A value for this column is required; no records can be in a SUPP-- dataset with a null value for QVAL.
12QORIGOriginChar
Record Qualifier



Because QVAL can represent a mixture of collected (on a CRF), derived, or assigned items, QORIG is used to indicate the origin of this data.


13QEVALEvaluatorChar
Record Qualifier



Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain objectively collected or derived data."ADJUDICATION COMMITTEE", "STATISTICIAN", "DATABASE ADMINISTRATOR", "CLINICAL COORDINATOR"

  • No labels