SDTM.SC

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	SC	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	SC	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	SC	USUBJID	Unique Subject Identifier	Char		Identifier	Req	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4	SC	SCSEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	SC	SCGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
6	SC	SCSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database.
7	SC	SCTESTCD	Subject Characteristic Short Name	Char	C74559	Topic	Req	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. Examples: "MARISTAT", "NATORIG".
8	SC	SCTEST	Subject Characteristic	Char	C103330	Synonym Qualifier	Req	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".
9	SC	SCCAT	Category for Subject Characteristic	Char		Grouping Qualifier	Perm	Used to define a category of related records.
10	SC	SCSCAT	Subcategory for Subject Characteristic	Char		Grouping Qualifier	Perm	A further categorization of the subject characteristic.
11	SC	SCORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the subject characteristic as originally received or collected.
12	SC	SCORRESU	Original Units	Char	C71620	Variable Qualifier	Perm	Original unit in which the data were collected. The unit for SCORRES.
13	SC	SCSTRESC	Character Result/Finding in Std Format	Char		Result Qualifier	Exp	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".
14	SC	SCSTRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier	Perm	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.
15	SC	SCSTRESU	Standard Units	Char	C71620	Variable Qualifier	Perm	Standardized unit used for SCSTRESC or SCSTRESN.
16	SC	SCSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate that the measurement was not done. Should be null if a result exists in SCORRES.
17	SC	SCREASND	Reason Not Performed	Char		Record Qualifier	Perm	Describes why the observation has no result. Example: "Subject refused". Used in conjunction with SCSTAT when value is "NOT DONE".
18	SC	VISITNUM	Visit Number	Num		Timing	Perm	Clinical encounter number. Numeric version of VISIT, used for sorting.
19	SC	VISIT	Visit Name	Char		Timing	Perm	Protocol-defined description of a clinical encounter. May be used in addition to VISITNUM and/or VISITDY.
20	SC	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
21	SC	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Number that gives the planned order of the element within the arm.
22	SC	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the start date/time at which the assessment was made.
23	SC	SCDTC	Date/Time of Collection	Char	ISO 8601 datetime or interval	Timing	Perm	Collection date and time of the subject characteristic represented in ISO 8601 character format.
24	SC	SCDY	Study Day of Examination	Num		Timing	Perm	Study day of collection, measured as integer days. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.