SDTM.IS

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	IS	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	IS	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	IS	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	IS	ISSEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	IS	ISGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
6	IS	ISREFID	Reference ID	Char		Identifier	Perm	Internal or external specimen identifier. Example: "458975-01".
7	IS	ISSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined identifier.
8	IS	ISTESTCD	Immunogenicity Test/Exam Short Name	Char	C120525	Topic	Req	Short name of the measurement, test, or examination described in ISTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in ISTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). ISTESTCD cannot contain characters other than letters, numbers, or underscores.
9	IS	ISTEST	Immunogenicity Test or Examination Name	Char	C120526	Synonym Qualifier	Req	Verbatim name of the test or examination used to obtain the measurement or finding. The value in ISTEST cannot be longer than 40 characters. Example: "Immunoglobulin E".
10	IS	ISCAT	Category for Immunogenicity Test	Char		Synonym Qualifier	Perm	Used to define a category of Topic-variable values across subjects. Example: "SEROLOGY".
11	IS	ISSCAT	Subcategory for Immunogenicity Test	Char		Grouping Qualifier	Perm	A further categorization of ISCAT.
12	IS	ISORRES	Results or Findings in Original Units	Char		Result Qualifier	Exp	Result of measurement or finding as originally received or collected.
13	IS	ISORRESU	Original Units	Char	C71620	Variable Qualifier	Exp	Original units in which the data were collected. The unit for ISORRES. Examples: "Index Value", "gpELISA", "unit/mL".
14	IS	ISSTRESC	Character Result/Finding in Std Format	Char		Result Qualifier	Exp	Contains the result value for all findings, copied or derived from ISORRES, in a standard format or in standard units. ISSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in ISSTRESN.
15	IS	ISSTRESN	Numeric Results/Findings in Std. Units	Num		Result Qualifier	Exp	Used for continuous or numeric results or findings in standard format; copied in numeric format from ISSTRESC. ISSTRESN should store all numeric test results or findings.
16	IS	ISSTRESU	Standard Units	Char	C71620	Variable Qualifier	Exp	Standardized units used for ISSTRESC and ISSTRESN. Examples: "Index Value", "gpELISA", "unit/mL".
17	IS	ISSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate a test was not done. Should be null if a result exists in ISORRES.
18	IS	ISREASND	Reason Not Done	Char		Record Qualifier	Perm	Describes why a measurement or test was not performed. Used in conjunction with ISSTAT when value is "NOT DONE".
19	IS	ISNAM	Vendor Name	Char		Record Qualifier	Perm	Name or identifier of the laboratory or vendor who provided the test results.
20	IS	ISSPEC	Specimen Type	Char	C78734	Record Qualifier	Perm	Defines the types of specimen used for a measurement. Example: "SERUM".
21	IS	ISMETHOD	Method of Test or Examination	Char	C85492	Record Qualifier	Perm	Method of the test or examination. Examples: "ELISA", "ELISPOT".
22	IS	ISLOBXFL	Last Observation Before Exposure Flag	Char	C66742	Record Qualifier	Perm	Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.
23	IS	ISBLFL	Baseline Flag	Char	C66742	Record Qualifier	Perm	Indicator used to identify a baseline value. Should be "Y" or null. Note that ISBLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset.
24	IS	ISLLOQ	Lower Limit of Quantitation	Num		Variable Qualifier	Exp	Indicates the lower limit of quantitation for an assay. Units will be those used for ISSTRESU.
25	IS	VISITNUM	Visit Number	Num		Timing	Exp	1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
26	IS	VISIT	Visit Name	Char		Timing	Perm	1. Protocol-defined description of a clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
27	IS	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
28	IS	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Number that gives the planned order of the Element within the Arm.
29	IS	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected.
30	IS	ISDTC	Date/Time of Collection	Char	ISO 8601	Timing	Exp	Collection date and time of an observation represented in ISO 8601.
31	IS	ISDY	Study Day of Visit/Collection/Exam	Num		Timing	Perm	Actual study day of visit/collection/exam expressed in integer days relative to sponsor-defined RFSTDTC in Demographics.