Subject Elements describes the actual order of elements that were traversed by the subject, together with the start date or start date and time and end date/time for each. Planned elements are described in the Trial Design model (see Section 5.1.1, Trial Arms and Trial Elements). Because actual data does not always follow the plan, the SDTM allows for descriptions of an unplanned element for subjects (SEUPDES).
See the implementation guides referenced in Section 1.2, Implementation Advice for this Model, for further guidance regarding use of additional identifier and timing variables.
Subject Elements—One Record per Actual Element per Subject
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 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, which must be "SE". | ||||
| 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 | SESEQ | Sequence Number | Num | Identifier | Sequence number to ensure uniqueness within the dataset. Should be assigned to be in a consistent chronological order. | ||||||
| 5 | ETCD | Element Code | Char | Topic | ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name. | ||||||
| 6 | ELEMENT | Description of Element | Char | Synonym Qualifier | ETCD | The name of the element. If ETCD has a value of "UNPLAN" then ELEMENT should be null. | |||||
| 7 | TAETORD | Planned Order of Element within Arm | Num | Timing | C83438 | An assigned numeric identifier that gives the planned order of the element within the trial arm of the study. | Value for the element within the subject's assigned arm. | ||||
| 8 | EPOCH | Epoch | Char | Timing | C71738 | A time period defined in the protocol with a study-specific purpose. | Value for the element within the subject's assigned arm. | ||||
| 9 | SESTDTC | Start Date/Time of Element | Char | ISO 8601 datetime or interval | Timing | Start date or start date and time for an element for each subject. | |||||
| 10 | SEENDTC | End Date/Time of Element | Char | ISO 8601 datetime or interval | Timing | End date/time of an element for each subject. | |||||
| 11 | SESTDY | Study Day of Start of Element | Num | Timing | Study day of start of element relative to the sponsor-defined RFSTDTC. | ||||||
| 12 | SEENDY | Study Day of End of Element | Num | Timing | Study day of end of element relative to the sponsor-defined RFSTDTC. | ||||||
| 13 | SEUPDES | Description of Unplanned Element | Char | Synonym Qualifier | ETCD | Description of what happened to the subject during an unplanned element. Used only if ETCD has the value of "UNPLAN". |
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