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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

SC

Identifier

Two-character abbreviation for the domain.

Req

USUBJID

Unique Subject Identifier

Char


Identifier

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

Req

SCSEQ

Sequence Number

Num


Identifier

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

Req

SCGRPID

Group Identifier

Char


Identifier

Used to tie together a block of related records in a single domain for a subject. This is not the dosing group number.

Perm

SCTESTCD

Subject Characteristic Short Name

Char

(SBCCDSND)

Topic

Short name of the measurement, test, or examination described in SCTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SCTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). SCTESTCD cannot contain characters other than letters, numbers, or underscores. Some extensible controlled values are: SPLRNAM, SPLRLOC, HAIRCOLR.

Req

SCTEST

Subject Characteristic

Char

(SBCSND)

Synonym Qualifier

Long name for SCTESTCD. The value in SCTEST cannot be longer than 40 characters. Examples: Test Subject Supplier, Test Subject Supplier Site, and Hair Coat Color.

Req

SCORRES

Result or Findings as Collected

Char


Result Qualifier

Result of the subject characteristic as originally received or collected.

Exp

SCORRESU

Unit of the Original Result

Char

(UNIT)

Variable Qualifier

The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list.

Perm

SCSTRESC

Standardized Result in Character Format

Char


Result Qualifier

Contains the result value for all findings, copied or derived from SCORRES in a standard format or standard units. SCSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in SCSTRESN. For example, if a test has results NONE, NEG, and NEGATIVE in SCORRES, these results effectively have the same meaning. In this case, they could be represented in standard format in SCSTRESC with a single term NEGATIVE.

Exp

SCSTRESN

Standardized Result in Numeric Format

Num


Result Qualifier

Used for numeric results or findings in standard format; contains the numeric form of SCSTRESC. SCSTRESN should store all numeric test results or findings.

Perm

SCSTRESU

Unit of the Standardized Result

Char

(UNIT)

Variable Qualifier

Standardized unit used for SCSTRESC and SCSTRESN.

Perm

SCDTC

Date/Time of Collection

Char

ISO 8601 datetime or interval

Timing

Date/Time of collection of the subject characteristic information, in ISO 8601 format.

Perm

SCDY

Study Day of Collection

Num


Timing

Study day of collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain.

Perm

Assumptions

  1. Subject Characteristics consists of data that is collected once per subject (per test). SC contains data that is either not normally expected to change during the study or whose change is not of interest after the initial collection.
  2. Applicants should ensure that data considered for submission in SC (e.g., hair coat, physical markings) do not actually belong in another domain. It is up to the applicant to determine whether such data have any information relevant to this domain.
  3. The structure for SC is based on the Findings general observation class. It is an extension of the Demographics (DM) dataset. Any data that can be submitted in the DM variables should not be submitted in SC.

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