SDTM.BS

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	BS	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	BS	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	BS	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	BS	SPDEVID	Sponsor Device Identifier	Char		Identifier	Perm	Sponsor-defined identifier for a device.
5	BS	BSSEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness within a dataset for a subject. May be any valid number (including decimals) and does not have to start at 1.
6	BS	BSGRPID	Group ID	Char		Identifier	Perm	Optional group identifier, used to link together a block of related records within a subject in a domain.
7	BS	BSREFID	Reference ID	Char		Identifier	Exp	Internal or external identifier such as lab specimen ID.
8	BS	BSSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined identifier.
9	BS	BSTESTCD	Biospecimen Test Short Name	Char	C124300	Topic	Req	Short character value for BSTEST used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters. Examples: VOLUME, RIN.
10	BS	BSTEST	Biospecimen Test Name	Char	C124299	Synonym Qualifier	Req	Long name for BSTESTCD. Examples: Volume, RNA Integrity Number.
11	BS	BSCAT	Category for Biospecimen Test	Char		Grouping Qualifier	Exp	Used to define a category of topic-variable values. Example: MEASUREMENT, QUALITY.
12	BS	BSSCAT	Subcategory for Biospecimen Test	Char		Grouping Qualifier	Perm	Used to define a further categorization of BSCAT values.
13	BS	BSORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the measurement or finding as originally received or collected.
14	BS	BSORRESU	Original Units	Char	C71620	Variable Qualifier	Exp	Unit for BSORRES. Examples: mg, mL.
15	BS	BSSTRESC	Character Result/Finding in Std Format	Char		Result Qualifier	Exp	Contains the result value for all findings, copied or derived from BSORRES in a standard format or standard units. BSSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in BSSTRESN.
16	BS	BSSTRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier	Exp	Used for continuous or numeric results or findings in standard format; copied in numeric format from BSSTRESC. BSSTRESN should store all numeric test results or findings.
17	BS	BSSTRESU	Standard Units	Char	C71620	Variable Qualifier	Exp	Standardized unit used for BSSTRESC and BSSTRESN.
18	BS	BSSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate that a test was not done, or was attempted but did not generate a result. Should be null or have a value of NOT DONE.
19	BS	BSREASND	Reason Test Not Done	Char		Record Qualifier	Perm	Reason not done. Used in conjunction with BSSTAT when value is NOT DONE.
20	BS	BSNAM	Vendor Name	Char		Record Qualifier	Perm	Name or identifier of the vendor (e.g., laboratory) that provided the test results.
21	BS	BSSPEC	Specimen Type	Char	C78734 C111114	Record Qualifier	Perm	Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE, SOFT TISSUE.
22	BS	BSANTREG	Anatomical Region of Specimen	Char		Variable Qualifier	Perm	Defines the specific anatomical or biological region of a tissue, organ specimen or the region from which the specimen is obtained, as defined in the protocol, such as a section or part of what is described in the BSSPEC variable. Examples: CORTEX, MEDULLA, MUCOSA.
23	BS	BSSPCCND	Specimen Condition	Char	C78733	Record Qualifier	Perm	Defines the condition of the specimen. Examples: HEMOLYZED, ICTERIC, LIPEMIC.
24	BS	BSMETHOD	Method of Test or Examination	Char	C85492	Record Qualifier	Perm	Method of the test or examination. Examples: SPECTROPHOTOMETRY, ELECTROPHORESIS.
25	BS	BSBLFL	Baseline Flag	Char	C66742	Record Qualifier	Perm	Indicator used to identify a baseline value.
26	BS	VISITNUM	Visit Number	Num		Timing	Exp	Clinical encounter number. Numeric version of VISIT, used for sorting.
27	BS	VISIT	Visit Name	Char		Timing	Perm	Protocol-defined description of clinical encounter.
28	BS	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of VISIT. Should be an integer.
29	BS	BSDTC	Date/Time of Specimen Collection	Char	ISO 8601 datetime or interval	Timing	Exp	Date and time of specimen collection.
30	BS	BSDY	Study Day of Specimen Collection	Num		Timing	Perm	Study day of specimen collection relative to the sponsor-defined RFSTDTC.
31	BS	BSTPT	Planned Time Point Name	Char		Timing	Perm	Text description of time when a measurement or observation should be taken as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See BSTPTNUM and BSTPTREF.
32	BS	BSTPTNUM	Planned Time Point Number	Num		Timing	Perm	Numerical version of BSTPT used in sorting.
33	BS	BSELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601 duration	Timing	Perm	Elapsed time relative to a planned fixed reference (BSTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable, but an interval, represented as ISO duration.
34	BS	BSTPTREF	Time Point Reference	Char		Timing	Perm	Name of the fixed reference point referred to by BSELTM, BSTPTNUM, and BSTPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL.
35	BS	BSRFTDTC	Date/Time of Reference Time Point	Char	ISO 8601 datetime or interval	Timing	Perm	Date/time for a fixed reference time point defined by BSTPTREF.