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	NHOID	Non-host Organism ID	Char		Identifier	Perm	Sponsor-defined identifier for a non-host organism which should only be used when the organism is the subject of the TEST. This variable should be populated with an intuitive name based on the identity of the non-host organism as reported by a lab (e.g., "A/California/7/2009 (H1N1)"). It is not to be used as a qualifier of the result in the record on which it appears.
5	IS	ISSEQ	Sequence Number	Num		Identifier	Req	Sequence number to ensure uniqueness of records within a dataset for a subject. May be any valid number (including decimals) and does not have to start at 1.
6	IS	ISGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
7	IS	ISREFID	Reference ID	Char		Identifier	Perm	Internal or external specimen identifier. Example: "458975-01".
8	IS	ISSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined identifier.
9	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.
10	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".
11	IS	ISTSTCND	Test Condition	Char	C181175	Variable Qualifier	Perm	Identifies any planned condition imposed by the assay system on the specimen at the time the test is performed.
12	IS	ISCNDAGT	Test Condition Agent	Char		Record Qualifier	Perm	The textual description of the agent used to impose a test condition. Examples are different stimulating agents used in immunoassays such as those in the Interferon Gamma Response assay (e.g., Mycobacterium tuberculosis ESAT-6, CFP-10, TB 7.7, Mitogen).
13	IS	ISBDAGNT	Binding Agent	Char	C85491 C181169	Variable Qualifier	Perm	Text description of the agent that is binding to the entity in the ISTEST variable. ISBDAGNT is used to indicate that there is a binding relationship between the entities in the ISTEST and ISBDAGNT variables, regardless of direction. \n ISBDAGNT is not a method qualifier. It should only be used when the actual interest of the measurement is the binding interaction between the 2 entities in ISTEST and ISBDAGNT. In other words, the combination of ISTEST and ISBDAGNT should describe the entity or the analyte being measured, without the need for additional variables. \n The binding agent may be (but is not limited to) a test article, a portion of the test article, a related compound, an endogenous molecule, an allergen, or an infectious agent.
14	IS	ISTSTOPO	Test Operational Objective	Char	C181170	Variable Qualifier	Perm	Text description of the high-level purpose of the test at the operational level. If populated, valid values are "SCREEN", "CONFIRM", and "QUANTIFY".
15	IS	ISMSCBCE	Molecule Secreted by Cells	Char		Variable Qualifier	Perm	Text description of the entity secreted by the cells represented in ISTEST. The combination of ISTEST and ISMSCBCE should describe the entity or the analyte being measured, without the need for additional variables.
16	IS	ISTSTDTL	Test Detail	Char		Variable Qualifier	Perm	Further description of ISTESTCD and ISTEST.
17	IS	ISCAT	Category for Immunogenicity Test	Char		Grouping Qualifier	Perm	Used to define a category of topic-variable values across subjects. Example: "SEROLOGY".
18	IS	ISSCAT	Subcategory for Immunogenicity Test	Char		Grouping Qualifier	Perm	A further categorization of ISCAT.
19	IS	ISORRES	Results or Findings in Original Units	Char		Result Qualifier	Exp	Result of the measurement or finding as originally received or collected.
20	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".
21	IS	ISORNRLO	Reference Range Lower Limit in Orig Unit	Char		Variable Qualifier	Exp	Lower end of reference range for continuous measurement in original units. Should be populated only for continuous results.
22	IS	ISORNRHI	Reference Range Upper Limit in Orig Unit	Char		Variable Qualifier	Exp	Upper end of reference range for continuous measurement in original units. Should be populated only for continuous results.
23	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.
24	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.
25	IS	ISSTRESU	Standard Units	Char	C71620	Variable Qualifier	Exp	Standardized units used for ISSTRESC and ISSTRESN. Examples: "Index Value", "gpELISA", "unit/mL".
26	IS	ISSTNRLO	Reference Range Lower Limit-Std Units	Num		Variable Qualifier	Exp	Lower end of reference range for continuous measurements for ISSTRESC/ISSTRESN in standardized units. Should be populated only for continuous results.
27	IS	ISSTNRHI	Reference Range Upper Limit-Std Units	Num		Variable Qualifier	Exp	Upper end of reference range for continuous measurements in standardized units. Should be populated only for continuous results.
28	IS	ISSTNRC	Reference Range for Char Rslt-Std Units	Char		Variable Qualifier	Perm	For normal range values that are character in ordinal scale or if categorical ranges were supplied. Examples: "-1 to +1", "NEGATIVE TO TRACE".
29	IS	ISNRIND	Reference Range Indicator	Char	C78736	Variable Qualifier	Exp	Indicates where the value falls with respect to reference range defined by ISORNRLO and ISORNRHI, ISSTNRLO and ISSTNRHI, or by ISSTNRC. Examples: "NORMAL", "ABNORMAL", "HIGH", "LOW". \n Sponsors should specify in the study metadata (Comments column in the Define-XML document) whether ISNRIND refers to the original or standard reference ranges and results. \n Should not be used to indicate clinical significance.
30	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.
31	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".
32	IS	ISNAM	Vendor Name	Char		Record Qualifier	Perm	Name or identifier of the laboratory or vendor who provided the test results.
33	IS	ISSPEC	Specimen Type	Char	C78734	Record Qualifier	Perm	Defines the types of specimen used for a measurement. Example: "SERUM".
34	IS	ISSPCCND	Specimen Condition	Char	C78733	Record Qualifier	Perm	Free or standardized text describing the condition of the specimen. Examples: "HEMOLYZED", "ICTERIC", "LIPEMIC".
35	IS	ISSPCUFL	Specimen Usability for the Test	Char	C66742	Record Qualifier	Perm	Describes the usability of the specimen for the test. The value will be "N" if the specimen is not usable, and null if the specimen is usable.
36	IS	ISMETHOD	Method of Test or Examination	Char	C85492	Record Qualifier	Perm	Method of the test or examination. Examples: "ELISA", "ELISPOT".
37	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.
38	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.
39	IS	ISDRVFL	Derived Flag	Char	C66742	Record Qualifier	Perm	Used to indicate a derived record. The value should be "Y" or null. Examples of records that might be derived for the submission datasets include those that represent the average of other records, do not come from the CRF, or are not as originally received or collected. If ISDRVFL="Y", then ISORRES may be null, with ISSTRESC and (if numeric) ISSTRESN having the derived value.
40	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.
41	IS	VISITNUM	Visit Number	Num		Timing	Exp	Clinical encounter number. Numeric version of VISIT, used for sorting.
42	IS	VISIT	Visit Name	Char		Timing	Perm	Protocol-defined description of a clinical encounter. May be used in addition to VISITNUM and/or VISITDY.
43	IS	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
44	IS	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Number that gives the planned order of the element within the arm.
45	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.
46	IS	ISDTC	Date/Time of Collection	Char	ISO 8601 datetime or interval	Timing	Exp	Collection date and time of an observation.
47	IS	ISENDTC	End Date/Time of Specimen Collection	Char	ISO 8601 datetime or interval	Timing	Perm	End date/time of the observation.
48	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.
49	IS	ISENDY	Study Day of End of Specimen Collection	Num		Timing	Perm	Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
50	IS	ISTPT	Planned Time Point Name	Char		Timing	Perm	Text description of time when specimen should be taken. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See ISTPTNUM and ISTPTREF. Examples: "Start", "5 min post".
51	IS	ISTPTNUM	Planned Time Point Number	Num		Timing	Perm	Numerical version of ISTPT to aid in sorting.
52	IS	ISELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601 duration	Timing	Perm	Planned elapsed time (in ISO 8601) relative to a planned fixed reference (ISTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date/time variable. Represented as ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by ISTPTREF, "PT8H" to represent the period of 8 hours after the reference point indicated by ISTPTREF.
53	IS	ISTPTREF	Time Point Reference	Char		Timing	Perm	Name of the fixed reference point referred to by ISELTM, ISTPTNUM, and ISTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".
54	IS	ISRFTDTC	Date/Time of Reference Time Point	Char	ISO 8601 datetime or interval	Timing	Perm	Date/time of the reference time point, ISTPTREF.