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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 OE STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 OE DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 OE 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 OE FOCID Focus of Study-Specific Interest Char C119013 Identifier Perm 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.
5 OE OESEQ Sequence Number Num Identifier Req Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
6 OE OEGRPID Group ID Char Identifier Perm Optional group identifier, used to link together a block of related records within a subject in a domain.
7 OE OELNKID Link ID Char Identifier Perm Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship.
8 OE OELNKGRP Link Group Char Identifier Perm Identifier used to link related records across domains. This will usually be a many-to-one relationship.
9 OE OETESTCD Short Name of Ophthalmic Test or Exam Char C117743 Topic Req 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".
10 OE OETEST Name of Ophthalmic Test or Exam Char C117742 Synonym Qualifier Req 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".
11 OE OETSTDTL Ophthalmic Test or Exam Detail Char Variable Qualifier Perm Further description of OETESTCD and OETEST.
12 OE OECAT Category for Ophthalmic Test or Exam Char Grouping Qualifier Perm Used to define a category of topic-variable values. Examples: "VISUAL ACUITY", "CONTRAST SENSITIVIY", "OCULAR COMFORT".
13 OE OESCAT Subcategory for Ophthalmic Test or Exam Char Grouping Qualifier Perm Used to define a further categorization of OECAT values. Examples: "HIGH CONTRAST" and "LOW CONTRAST" when OECAT is "VISUAL ACUITY".
14 OE OEORRES Result or Finding in Original Units Char Result Qualifier Exp Result of the measurement or finding as originally received or collected. Examples: "120", "<1, NORMAL", "RED SPOT VISIBLE".
15 OE OEORRESU Original Units Char C71620 Variable Qualifier Exp Original unit for OEORRES. Examples: "mm", "um".
16 OE OEORNRLO Normal Range Lower Limit-Original Units Char Variable Qualifier Perm Lower end of normal range or reference range for results stored in OEORRES.
17 OE OEORNRHI Normal Range Upper Limit-Original Units Char Variable Qualifier Perm Upper end of normal range or reference range for results stored in OEORRES.
18 OE OESTRESC Character Result/Finding in Std Format Char Result Qualifier Exp 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.
19 OE OESTRESN Numeric Result/Finding in Standard Units Num Result Qualifier Exp 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.
20 OE OESTRESU Standard Units Char C71620 Variable Qualifier Exp Standardized units used for OESTRESC and OESTRESN. Examples: "mm", "um".
21 OE OESTNRLO Normal Range Lower Limit-Standard Units Num Variable Qualifier Perm Lower end of normal range or reference range for standardized results (e.g., OESTRESC, OESTRESN) represented in standardized units (OESTRESU).
22 OE OESTNRHI Normal Range Upper Limit-Standard Units Num Variable Qualifier Perm Upper end of normal range or reference range for standardized results (e.g., OESTRESC, OESTRESN) represented in standardized units (OESTRESU).
23 OE OESTNRC Normal Range for Character Results Char Variable Qualifier Perm Normal range or reference range for results stored in OESTRESC that are character in ordinal or categorical scale. Example: "Negative to Trace".
24 OE OENRIND Normal/Reference Range Indicator Char C78736 Variable Qualifier Perm 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".
25 OE OERESCAT Result Category Char Variable Qualifier Perm 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.
26 OE OESTAT Completion Status Char C66789 Record Qualifier Perm 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".
27 OE OEREASND Reason Not Done Char Record Qualifier Perm Reason not done. Used in conjunction with OESTAT when value is "NOT DONE".
28 OE OEXFN External File Path Char Record Qualifier Perm Filename for an external file, such as one for a retinal OCT image.
29 OE OELOC Location Used for the Measurement Char C74456 Record Qualifier Exp 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.
30 OE OELAT Laterality Char C99073 Variable Qualifier Exp Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL".
31 OE OEDIR Directionality Char C99074 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL".
32 OE OEPORTOT Portion or Totality Char C99075 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing the distribution, which means arrangement of, apportioning of. Examples: "ENTIRE", "SINGLE", "SEGMENT", "MANY".
33 OE OEMETHOD Method of Test or Examination Char C85492 Record Qualifier Exp 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.
34 OE OELOBXFL Last Observation Before Exposure Flag Char C66742 Record Qualifier Exp Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.
35 OE OEBLFL Baseline Flag Char C66742 Record Qualifier Perm 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.
36 OE OEDRVFL Derived Flag Char C66742 Record Qualifier Perm 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.
37 OE OEEVAL Evaluator Char C78735 Record Qualifier Perm 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".
38 OE OEEVALID Evaluator Identifier Char C96777 Variable Qualifier Perm Used to distinguish multiple evaluators with the same role recorded in OEEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2".
39 OE OEACPTFL Accepted Record Flag Char C66742 Record Qualifier Perm 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.
40 OE OEREPNUM Repetition Number Num Record Qualifier Perm 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.
41 OE VISITNUM Visit Number Num Timing Exp Clinical encounter number. Numeric version of VISIT, used for sorting.
42 OE VISIT Visit Name Char Timing Perm Protocol-defined description of a clinical encounter.
43 OE VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the visit based upon RFSTDTC in Demographics.
44 OE TAETORD Planned Order of Element within Arm Num Timing Perm Number that gives the planned order of the Element within the Arm for the Element in which the assessment was made.
45 OE EPOCH Epoch Char C99079 Timing Perm Epoch associated with the date/time at which the assessment was made.
46 OE OEDTC Date/Time of Collection Char ISO 8601 Timing Exp Collection date/time of the observation.
47 OE OEDY Study Day of Visit/Collection/Exam Num Timing Exp Actual study day of observation/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
48 OE OETPT Planned Time Point Name Char Timing Perm 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.
49 OE OETPTNUM Planned Time Point Number Num Timing Perm Numeric version of planned time point used in sorting.
50 OE OEELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm 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.
51 OE OETPTREF Time Point Reference Char Timing Perm Description of the fixed reference point referred to by OETPT, OETPTNUM, and OEELTM.
52 OE OERFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time of the reference time point, OETPTREF.