Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 SR 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 SR 2 DOMAIN Domain Abbreviation Char SR Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 SR 3 USUBJID Unique Subject Identifier Char Identifier Identifier used to uniquely identify a subject across submission. Req
SDTMIG 3.3 SR 4 SRSEQ 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 SR 5 SRGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. Perm
SDTMIG 3.3 SR 6 SRREFID Reference ID Char Identifier Internal or external specimen identifier. Example: "Specimen ID". Perm
SDTMIG 3.3 SR 7 SRSPID Sponsor-Defined Identifier Char Identifier Sponsor-defined identifier. Perm
SDTMIG 3.3 SR 8 SRTESTCD Skin Response Test or Exam Short Name Char (SRTESTCD) Topic Short name of the measurement, test, or examination described in SRTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SRTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). SRTESTCD cannot contain characters other than letters, numbers, or underscores. Req
SDTMIG 3.3 SR 9 SRTEST Skin Response Test or Examination Name Char (SRTEST) Synonym Qualifier Verbatim name of the test or examination used to obtain the measurement or finding. The value in SRTEST cannot be longer than 40 characters. Example: "Wheal Diameter". Req
SDTMIG 3.3 SR 10 SROBJ Object of the Observation Char Record Qualifier Used to describe the object or focal point of the findings observation that is represented by --TEST. Examples: the dose of the immunogenic material or the allergen associated with the response (e.g., "Johnson Grass IgE 0.15 BAU mL"). Req
SDTMIG 3.3 SR 11 SRCAT Category for Test Char Grouping Qualifier Used to define a category of Topic-variable values across subjects. Perm
SDTMIG 3.3 SR 12 SRSCAT Subcategory for Test Char Grouping Qualifier A further categorization of SRCAT values. Perm
SDTMIG 3.3 SR 13 SRORRES Results or Findings in Original Units Char Result Qualifier Results of measurement or finding as originally received or collected. Exp
SDTMIG 3.3 SR 14 SRORRESU Original Units Char (UNIT) Variable Qualifier Original units in which the data were collected. The unit for SRORRES. Example: "mm". Exp
SDTMIG 3.3 SR 15 SRSTRESC Character Result/Finding in Std Format Char Result Qualifier Contains the result value for all findings, copied or derived from SRORRES in a standard format or in standard units. SRSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in SRSTRESN. Exp
SDTMIG 3.3 SR 16 SRSTRESN 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 SRSTRESC. SRSTRESN should store all numeric test results or findings. Exp
SDTMIG 3.3 SR 17 SRSTRESU Standard Units Char (UNIT) Variable Qualifier Standardized units used for SRSTRESC and SRSTRESN, Example: "mm". Exp
SDTMIG 3.3 SR 18 SRSTAT Completion Status Char (ND) Record Qualifier Used to indicate exam not done. Should be null if a result exists in SRORRES. Perm
SDTMIG 3.3 SR 19 SRREASND Reason Not Done Char Record Qualifier Describes why a measurement or test was not performed. Used in conjunction with SRSTAT when value is "NOT DONE". Perm
SDTMIG 3.3 SR 20 SRNAM Vendor Name Char Record Qualifier Name or identifier of the laboratory or vendor who provided the test results. Perm
SDTMIG 3.3 SR 21 SRSPEC Specimen Type Char (SPECTYPE) Record Qualifier Defines the types of specimen used for a measurement. Example: "SKIN". Perm
SDTMIG 3.3 SR 22 SRLOC Location Used for Measurement Char (LOC) Record Qualifier Location relevant to the collection of the measurement. Perm
SDTMIG 3.3 SR 23 SRLAT Laterality Char (LAT) Variable Qualifier Qualifier for anatomical location further detailing laterality of intervention administration. Examples: "RIGHT", "LEFT", "BILATERAL". Perm
SDTMIG 3.3 SR 24 SRMETHOD Method of Test or Examination Char (METHOD) Record Qualifier Method of test or examination. Examples: "ELISA", "EIA", "MICRONEUTRALIZATION ASSAY", "PRNT" (Plaque Reduction Neutralization Tests). Perm
SDTMIG 3.3 SR 25 SRLOBXFL 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 SR 26 SRBLFL Baseline Flag Char (NY) Record Qualifier Indicator used to identify a baseline value. The value should be "Y" or null. Note that SRBLFL is retained for backward compatibility. The authoritative baseline flag for statistical analysis is in an ADaM dataset. Perm
SDTMIG 3.3 SR 27 SREVAL Evaluator Char (EVAL) Record Qualifier Role of person who provided 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: "INVESTIGATOR", "ADJUDICATION COMMITTEE", "VENDOR". Perm
SDTMIG 3.3 SR 28 VISITNUM Visit Number Num Timing 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 SR 29 VISIT Visit Name Char Timing 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY. Perm
SDTMIG 3.3 SR 30 VISITDY Planned Study Day of Visit Num Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm
SDTMIG 3.3 SR 31 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 SR 32 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the date/time of the observation. Examples: "SCREENING", "TREATMENT", and "FOLLOW-UP". Perm
SDTMIG 3.3 SR 33 SRDTC Date/Time of Collection Char ISO 8601 Timing Collection date and time of an observation represented in ISO 8601. Exp
SDTMIG 3.3 SR 34 SRDY 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
SDTMIG 3.3 SR 35 SRTPT Planned Time Point Name Char Timing 1. Text description of time when measurement should be taken. 2. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See SRTPTNUM and SRTPTREF. Examples: "Start", "5 min post". Perm
SDTMIG 3.3 SR 36 SRTPTNUM Planned Time Point Number Num Timing Numerical version of SRTPT to aid in sorting. Perm
SDTMIG 3.3 SR 37 SRELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Planned elapsed time (in ISO 8601) relative to a fixed time point reference (SRTPTREF). Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by EGTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by SRTPTREF. Perm
SDTMIG 3.3 SR 38 SRTPTREF Time Point Reference Char Timing Name of the fixed reference point referred to by SRELTM, SRTPTNUM, and SRTPT. Example: "INTRADERMAL INJECTION". Perm
SDTMIG 3.3 SR 39 SRRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Date/time of the reference time point, SRTPTREF. Perm