Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 IS 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 IS 2 DOMAIN Domain Abbreviation Char IS Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 IS 3 USUBJID Unique Subject Identifier Char Identifier Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Req
SDTMIG 3.3 IS 4 ISSEQ Sequence Number Num Identifier Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. Req
SDTMIG 3.3 IS 5 ISGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. Perm
SDTMIG 3.3 IS 6 ISREFID Reference ID Char Identifier Internal or external specimen identifier. Example: "458975-01". Perm
SDTMIG 3.3 IS 7 ISSPID Sponsor-Defined Identifier Char Identifier Sponsor-defined identifier. Perm
SDTMIG 3.3 IS 8 ISTESTCD Immunogenicity Test/Exam Short Name Char (ISTESTCD) Topic 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. Req
SDTMIG 3.3 IS 9 ISTEST Immunogenicity Test or Examination Name Char (ISTEST) Synonym Qualifier 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". Req
SDTMIG 3.3 IS 10 ISCAT Category for Immunogenicity Test Char Synonym Qualifier Used to define a category of Topic-variable values across subjects. Example: "SEROLOGY". Perm
SDTMIG 3.3 IS 11 ISSCAT Subcategory for Immunogenicity Test Char Grouping Qualifier A further categorization of ISCAT. Perm
SDTMIG 3.3 IS 12 ISORRES Results or Findings in Original Units Char Result Qualifier Result of measurement or finding as originally received or collected. Exp
SDTMIG 3.3 IS 13 ISORRESU Original Units Char (UNIT) Variable Qualifier Original units in which the data were collected. The unit for ISORRES. Examples: "Index Value", "gpELISA", "unit/mL". Exp
SDTMIG 3.3 IS 14 ISSTRESC Character Result/Finding in Std Format Char Result Qualifier 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. Exp
SDTMIG 3.3 IS 15 ISSTRESN Numeric Results/Findings in Std. Units Num Result Qualifier 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. Exp
SDTMIG 3.3 IS 16 ISSTRESU Standard Units Char (UNIT) Variable Qualifier Standardized units used for ISSTRESC and ISSTRESN. Examples: "Index Value", "gpELISA", "unit/mL". Exp
SDTMIG 3.3 IS 17 ISSTAT Completion Status Char (ND) Record Qualifier Used to indicate a test was not done. Should be null if a result exists in ISORRES. Perm
SDTMIG 3.3 IS 18 ISREASND Reason Not Done Char Record Qualifier Describes why a measurement or test was not performed. Used in conjunction with ISSTAT when value is "NOT DONE". Perm
SDTMIG 3.3 IS 19 ISNAM Vendor Name Char Record Qualifier Name or identifier of the laboratory or vendor who provided the test results. Perm
SDTMIG 3.3 IS 20 ISSPEC Specimen Type Char (SPECTYPE) Record Qualifier Defines the types of specimen used for a measurement. Example: "SERUM". Perm
SDTMIG 3.3 IS 21 ISMETHOD Method of Test or Examination Char (METHOD) Record Qualifier Method of the test or examination. Examples: "ELISA", "ELISPOT". Perm
SDTMIG 3.3 IS 22 ISLOBXFL Last Observation Before Exposure Flag Char (NY) Record Qualifier Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null. Perm
SDTMIG 3.3 IS 23 ISBLFL Baseline Flag Char (NY) Record Qualifier 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. Perm
SDTMIG 3.3 IS 24 ISLLOQ Lower Limit of Quantitation Num Variable Qualifier Indicates the lower limit of quantitation for an assay. Units will be those used for ISSTRESU. Exp
SDTMIG 3.3 IS 25 VISITNUM Visit Number Num Timing 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 IS 26 VISIT Visit Name Char Timing 1. Protocol-defined description of a clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY. Perm
SDTMIG 3.3 IS 27 VISITDY Planned Study Day of Visit Num Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm
SDTMIG 3.3 IS 28 TAETORD Planned Order of Element within Arm Num Timing Number that gives the planned order of the Element within the Arm. Perm
SDTMIG 3.3 IS 29 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected. Perm
SDTMIG 3.3 IS 30 ISDTC Date/Time of Collection Char ISO 8601 Timing Collection date and time of an observation represented in ISO 8601. Exp
SDTMIG 3.3 IS 31 ISDY Study Day of Visit/Collection/Exam Num Timing Actual study day of visit/collection/exam expressed in integer days relative to sponsor-defined RFSTDTC in Demographics. Perm