| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
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 |
| 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 ID |
Char |
Identifier |
Used to tie together a block of related records in a single
domain for a subject. |
Perm |
| SCSPID |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined reference number. Perhaps preprinted on the
CRF as an explicit line identifier or defined in the sponsor's
operational database. |
Perm |
| SCTESTCD |
Subject Characteristic Short Name |
Char |
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. Example:
"MARISTAT", "NATORIG". |
Req |
| SCTEST |
Subject Characteristic |
Char |
Synonym Qualifier |
Verbatim name of the test or examination used to obtain the
measurement or finding. The value in SCTEST cannot be longer than 40
characters. Examples: "Marital Status", "National Origin". |
Req |
| SCCAT |
Category for Subject Characteristic |
Char |
Grouping Qualifier |
Used to define a category of related records. |
Perm |
| SCSCAT |
Subcategory for Subject Characteristic |
Char |
Grouping Qualifier |
A further categorization of the subject characteristic. |
Perm |
| SCORRES |
Result or Finding in Original Units |
Char |
Result Qualifier |
Result of the subject characteristic as originally received
or collected. |
Exp |
| SCORRESU |
Original Units |
Char |
Variable Qualifier |
Original unit in which the data were collected. The unit for
SCORRES. |
Perm |
| SCSTRESC |
Character Result/Finding in Std 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, and these results effectively have the same
meaning, they could be represented in standard format in SCSTRESC as
"NEGATIVE". |
Exp |
| SCSTRESN |
Numeric Result/Finding in Standard Units |
Num |
Result Qualifier |
Used for continuous or numeric results or findings in
standard format; copied in numeric format from SCSTRESC. SCSTRESN
should store all numeric test results or findings. |
Perm |
| SCSTRESU |
Standard Units |
Char |
Variable Qualifier |
Standardized unit used for SCSTRESC or SCSTRESN. |
Perm |
| SCSTAT |
Completion Status |
Char |
Record Qualifier |
Used to indicate that the measurement was not done. Should
be null if a result exists in SCORRES. |
Perm |
| SCREASND |
Reason Not Performed |
Char |
Record Qualifier |
Describes why the observation has no result. Example:
"Subject refused". Used in conjunction with SCSTAT when value is
"NOT DONE". |
Perm |
| TAETORD |
Planned Order of Element within Arm |
Num |
Timing |
Number that gives the planned order of the Element within
the Arm. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the start date/time at which the
assessment was made. |
Perm |
| SCDTC |
Date/Time of Collection |
Char |
Timing |
Collection date and time of the subject characteristic
represented in ISO 8601 character format. |
Perm |
| SCDY |
Study Day of Examination |
Num |
Timing |
Study day of collection, measured as integer days. Algorithm
for calculations must be relative to the sponsor-defined RFSTDTC
variable in Demographics. |
Perm |