Description

A special-purpose domain that contains the actual order of elements followed by the subject, together with the start date/time and end date/time for each element.

se.xpt, Subject Elements — Special-Purpose. One record per element experienced per subject, Tabulation.


Specification

TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1

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

Controlled Terms, Codelist, or Format

Role

CDISC Notes

Core

STUDYID

Study Identifier

Char


Identifier

Unique identifier for a study.

Req

DOMAIN

Domain Abbreviation

Char

SE

Identifier

Two-character abbreviation for the domain.

Req

USUBJID

Unique Subject Identifier

Char


Identifier

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

Req

SESEQ

Sequence Number

Num


Identifier

Sequence number given to ensure uniqueness of subject records within a USUBJID within a domain. May be any valid number.

Req

ETCD

Element Code

Char


Topic

ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions.

Req

ELEMENT

Description of Element

Char


Synonym Qualifier

The name of the Element..

Perm

SESTDTC

Start Date/Time of Element

Char

ISO 8601 datetime or interval

Timing

Start date/time for an Element for each subject, in ISO 8601 format.

Req

SEENDTC

End Date/Time of Element

Char

ISO 8601 datetime or interval

Timing

End date/time for an Element for each subject, in ISO 8601 format.

Exp

SEUPDES

Description of Unplanned Element

Char


Synonym Qualifier

Description of what happened to the subject during an unplanned Element. Used only if ETCD has the value of UNPLAN.

Perm


Assumptions

  1. The Subject Elements domain allows the submission of data on the individual experience: the actual timing and sequence of elements a subject experienced. There are, by definition, no time gaps between elements; therefore, the value of SEENDTC for one element will always be immediately before or the same as the value of SESTDTC for the next element. Each element continues until the time at which the next element begins, and a subject must be in only 1 element at a time.
  2. For any particular subject, the dates in the SE table are the dates when the transition events identified in the TE table occurred.
  3. If the start date/time of an element was not collected directly, the method used to infer the element start date/time should be explained in the Comments column of the data definition file.
  4. If the applicant decides that the subject's experience for a particular period of time cannot be represented with one of the planned elements, then that period of time should be represented as an unplanned element.
  5. For unplanned elements, ETCD should be populated with "UNPLAN", ELEMENT should be left blank, and SEUPDES should be populated with a description of the unplanned element.
  6. With the exception of unplanned elements, the values of ETCD used in this domain should match values for the same element in the TE dataset.
  7. The values of SESTDTC provide the chronological order of the actual subject elements. SESEQ should be assigned to be consistent with the chronological order. Note that the requirement that SESEQ be consistent with chronological order is more stringent than in most other domains, where --SEQ values need only be unique within subject.

« SEND Subject Characteristics (SC)

SEND Supplemental Qualifiers (SUPP--) »

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