STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3 general observation classes. Each general class domain must also include at least 1 of the following subject identifiers: USUBJID, SPDEVID, POOLID, SPTOBID, or GTREFID (in the GT domain only).
All identifier variables are allowed for any domain based on one of the 3 general observation classes, unless otherwise noted in the Usage Restrictions.
All Observation Classes—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 | Format | Role | Variable(s) Qualified | 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 ID | Char | Identifier | Tobacco IG only | A sequence of characters used by the applicant to uniquely identify a tobacco product. | |||||
| 7 | IGDCMPID | 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 | 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
SDTM & Related IG Metadata Check User Macros FAQ
- Content: Variable Name SPTOBID NEW VAR is longer than 8 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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