SEND Subject Characteristics (SC)

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