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
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 treatment group number.
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.
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.
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.
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 sponsor-defined RFSTDTC variable in the Demographics (DM) domain.