SDTM.SS

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	SS	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	SS	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	SS	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	SS	SSSEQ	Sequence Number	Num		Identifier	Req	Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	SS	SSGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
6	SS	SSSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number from the procedure or test page.
7	SS	SSTESTCD	Status Short Name	Char	C124305	Topic	Req	Short name of the status assessment described in SSTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SSTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). SSTESTCD cannot contain characters other than letters, numbers, or underscores. Example: SURVSTAT
8	SS	SSTEST	Status Name	Char	C124306	Synonym Qualifier	Req	Verbatim name of the status assessment used to obtain the finding. The value in SSTEST cannot be longer than 40 characters. Example: Survival Status
9	SS	SSCAT	Category for Assessment	Char		Grouping Qualifier	Perm	Used to categorize observations across subjects.
10	SS	SSSCAT	Subcategory for Assessment	Char		Grouping Qualifier	Perm	A further categorization.
11	SS	SSORRES	Result or Finding Original Result	Char		Result Qualifier	Exp	Result of the status assessment finding as originally received or collected.
12	SS	SSSTRESC	Character Result/Finding in Std Format	Char		Result Qualifier	Exp	Contains the result value for all findings, copied or derived from SSORRES in a standard format.
13	SS	SSSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate a status assessment was not done. Should be null if a result exists in SSORRES.
14	SS	SSREASND	Reason Assessment Not Performed	Char		Record Qualifier	Perm	Describes why an assessment was not performed. Example: SUBJECT REFUSED. Used in conjunction with SSSTAT when value is NOT DONE.
15	SS	SSEVAL	Evaluator	Char	C78735	Record Qualifier	Perm	Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain collected or derived data. Examples: CAREGIVER, ADJUDICATION COMMITTEE, FRIEND.
16	SS	VISITNUM	Visit Number	Num		Timing	Exp	1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
17	SS	VISIT	Visit Name	Char		Timing	Perm	1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
18	SS	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
19	SS	SSDTC	Date/Time of Assessment	Char	ISO 8601	Timing	Exp
20	SS	SSDY	Study Day of Assessment	Num		Timing	Perm	1. Study day of the test, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.