Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 OE 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 OE 2 DOMAIN Domain Abbreviation Char OE Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 OE 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 OE 4 FOCID Focus of Study-Specific Interest Char (OEFOCUS) Identifier Identification of a focus of study-specific interest on or within a subject or specimen as called out in the protocol for which a measurement, test, or examination was performed. Perm
SDTMIG 3.3 OE 5 OESEQ 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 OE 6 OEGRPID Group ID Char Identifier Optional group identifier, used to link together a block of related records within a subject in a domain. Perm
SDTMIG 3.3 OE 7 OELNKID Link ID Char Identifier Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship. Perm
SDTMIG 3.3 OE 8 OELNKGRP Link Group Char Identifier Identifier used to link related records across domains. This will usually be a many-to-one relationship. Perm
SDTMIG 3.3 OE 9 OETESTCD Short Name of Ophthalmic Test or Exam Char (OETESTCD) Topic Short character value for OETEST used as a column name when converting a dataset from a vertical format to a horizontal format. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in OETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). OETESTCD cannot contain characters other than letters, numbers, or underscores. Example: "NUMLCOR". Req
SDTMIG 3.3 OE 10 OETEST Name of Ophthalmic Test or Exam Char (OETEST) Synonym Qualifier Long name for the test or examination used to obtain the measurement or finding. The value in OETEST cannot be longer than 40 characters. Example: Number of Letters Correct for OETESTCD = "NUMLCOR". Req
SDTMIG 3.3 OE 11 OETSTDTL Ophthalmic Test or Exam Detail Char Variable Qualifier Further description of OETESTCD and OETEST. Perm
SDTMIG 3.3 OE 12 OECAT Category for Ophthalmic Test or Exam Char Grouping Qualifier Used to define a category of topic-variable values. Examples: "VISUAL ACUITY", "CONTRAST SENSITIVIY", "OCULAR COMFORT". Perm
SDTMIG 3.3 OE 13 OESCAT Subcategory for Ophthalmic Test or Exam Char Grouping Qualifier Used to define a further categorization of OECAT values. Examples: "HIGH CONTRAST" and "LOW CONTRAST" when OECAT is "VISUAL ACUITY". Perm
SDTMIG 3.3 OE 14 OEORRES Result or Finding in Original Units Char Result Qualifier Result of the measurement or finding as originally received or collected. Examples: "120", "<1, NORMAL", "RED SPOT VISIBLE". Exp
SDTMIG 3.3 OE 15 OEORRESU Original Units Char (UNIT) Variable Qualifier Original unit for OEORRES. Examples: "mm", "um". Exp
SDTMIG 3.3 OE 16 OEORNRLO Normal Range Lower Limit-Original Units Char Variable Qualifier Lower end of normal range or reference range for results stored in OEORRES. Perm
SDTMIG 3.3 OE 17 OEORNRHI Normal Range Upper Limit-Original Units Char Variable Qualifier Upper end of normal range or reference range for results stored in OEORRES. Perm
SDTMIG 3.3 OE 18 OESTRESC Character Result/Finding in Std Format Char Result Qualifier Contains the result value for all findings, copied or derived from OEORRES in a standard format or in standard units. OESTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in OESTRESN. Exp
SDTMIG 3.3 OE 19 OESTRESN Numeric Result/Finding in Standard Units Num Result Qualifier Used for continuous or numeric results or findings in standard format; copied in numeric format from OESTRESC. OESTRESN should store all numeric test results or findings. Exp
SDTMIG 3.3 OE 20 OESTRESU Standard Units Char (UNIT) Variable Qualifier Standardized units used for OESTRESC and OESTRESN. Examples: "mm", "um". Exp
SDTMIG 3.3 OE 21 OESTNRLO Normal Range Lower Limit-Standard Units Num Variable Qualifier Lower end of normal range or reference range for standardized results (e.g., OESTRESC, OESTRESN) represented in standardized units (OESTRESU). Perm
SDTMIG 3.3 OE 22 OESTNRHI Normal Range Upper Limit-Standard Units Num Variable Qualifier Upper end of normal range or reference range for standardized results (e.g., OESTRESC, OESTRESN) represented in standardized units (OESTRESU). Perm
SDTMIG 3.3 OE 23 OESTNRC Normal Range for Character Results Char Variable Qualifier Normal range or reference range for results stored in OESTRESC that are character in ordinal or categorical scale. Example: "Negative to Trace". Perm
SDTMIG 3.3 OE 24 OENRIND Normal/Reference Range Indicator Char (NRIND) Variable Qualifier Used to indicate the value is outside the normal range or reference range. May be defined by OEORNRLO and OEORNRHI or other objective criteria. Examples: "Y", "N"; "HIGH", "LOW", "NORMAL", "ABNORMAL". Perm
SDTMIG 3.3 OE 25 OERESCAT Result Category Char Variable Qualifier Used to categorize the result of a finding or medical status per interpretation of test results. Examples: "POSITIVE", "NEGATIVE". The variable OERESCAT is not meant to replace the use of OENRIND for cases where normal ranges are provided. Perm
SDTMIG 3.3 OE 26 OESTAT Completion Status Char (ND) Record Qualifier Used to indicate that a question was not asked or a test was not done, or a test was attempted but did not generate a result. Should be null or have a value of "NOT DONE". Perm
SDTMIG 3.3 OE 27 OEREASND Reason Not Done Char Record Qualifier Reason not done. Used in conjunction with OESTAT when value is "NOT DONE". Perm
SDTMIG 3.3 OE 28 OEXFN External File Path Char Record Qualifier Filename for an external file, such as one for a retinal OCT image. Perm
SDTMIG 3.3 OE 29 OELOC Location Used for the Measurement Char (LOC) Record Qualifier Anatomical location of the subject relevant to the collection of the measurement. Examples: "EYE" for a finding record relative to the complete eye, "RETINA" for a measurement or assessment of only the retina. Exp
SDTMIG 3.3 OE 30 OELAT Laterality Char (LAT) Variable Qualifier Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". Exp
SDTMIG 3.3 OE 31 OEDIR Directionality Char (DIR) Variable Qualifier Qualifier for anatomical location or specimen further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL". Perm
SDTMIG 3.3 OE 32 OEPORTOT Portion or Totality Char (PORTOT) Variable Qualifier Qualifier for anatomical location or specimen further detailing the distribution, which means arrangement of, apportioning of. Examples: "ENTIRE", "SINGLE", "SEGMENT", "MANY". Perm
SDTMIG 3.3 OE 33 OEMETHOD Method of Test or Examination Char (METHOD) Record Qualifier Method of the test or examination. Example: "ETDRS EYE CHART" for OETESTCD = "NUMLCOR". The different methods may offer different functionality or granularity, affecting the set of results and associated meaning. Exp
SDTMIG 3.3 OE 34 OELOBXFL 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. Exp
SDTMIG 3.3 OE 35 OEBLFL Baseline Flag Char (NY) Record Qualifier Indicator used to identify a baseline value. Should be "Y" or null. Note that OEBLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset. Perm
SDTMIG 3.3 OE 36 OEDRVFL Derived Flag Char (NY) Record Qualifier Used to indicate a derived record (e.g., a record that represents the average of other records such as a computed baseline). Should be "Y" or null. Perm
SDTMIG 3.3 OE 37 OEEVAL Evaluator Char (EVAL) Record Qualifier Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Examples: "INDEPENDENT ASSESSOR", "INVESTIGATOR". Perm
SDTMIG 3.3 OE 38 OEEVALID Evaluator Identifier Char (MEDEVAL) Variable Qualifier Used to distinguish multiple evaluators with the same role recorded in OEEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2". Perm
SDTMIG 3.3 OE 39 OEACPTFL Accepted Record Flag Char (NY) Record Qualifier In cases where more than one assessor provides an evaluation of a result or response, this flag identifies the record that is considered, by an independent assessor, to be the accepted evaluation. Expected to be "Y" or null. Perm
SDTMIG 3.3 OE 40 OEREPNUM Repetition Number Num Record Qualifier The incidence number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary, e.g., within a time point or within a visit. For example, multiple measurements of blood pressure or multiple analyses of a sample. Perm
SDTMIG 3.3 OE 41 VISITNUM Visit Number Num Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 OE 42 VISIT Visit Name Char Timing Protocol-defined description of a clinical encounter. Perm
SDTMIG 3.3 OE 43 VISITDY Planned Study Day of Visit Num Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm
SDTMIG 3.3 OE 44 TAETORD Planned Order of Element within Arm Num Timing Number that gives the planned order of the Element within the Arm for the Element in which the assessment was made. Perm
SDTMIG 3.3 OE 45 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the date/time at which the assessment was made. Perm
SDTMIG 3.3 OE 46 OEDTC Date/Time of Collection Char ISO 8601 Timing Collection date/time of the observation. Exp
SDTMIG 3.3 OE 47 OEDY Study Day of Visit/Collection/Exam Num Timing Actual study day of observation/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. Exp
SDTMIG 3.3 OE 48 OETPT Planned Time Point Name Char Timing 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. Perm
SDTMIG 3.3 OE 49 OETPTNUM Planned Time Point Number Num Timing Numeric version of planned time point used in sorting. Perm
SDTMIG 3.3 OE 50 OEELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Planned elapsed time relative to a planned fixed reference (OETPTREF) such as "Previous Dose" or "Previous Meal". 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. Perm
SDTMIG 3.3 OE 51 OETPTREF Time Point Reference Char Timing Description of the fixed reference point referred to by OETPT, OETPTNUM, and OEELTM. Perm
SDTMIG 3.3 OE 52 OERFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Date/time of the reference time point, OETPTREF. Perm