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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 RE STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 RE DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 RE 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 RE SPDEVID Sponsor Device Identifier Char Identifier Perm Sponsor-defined identifier for a device.
5 RE RESEQ 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 RE REGRPID Group ID Char Identifier Perm Optional group identifier, used to link together a block of related records within a subject in a domain.
7 RE REREFID Reference ID Char Identifier Perm Optional internal or external procedure identifier.
8 RE RESPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined identifier. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database.
9 RE RELNKID 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.
10 RE RELNKGRP Link Group Char Identifier Perm Identifier used to link related records across domains. This will usually be a many-to-one relationship.
11 RE RETESTCD Short Name of Respiratory Test Char C111106 Topic Req Short name of the measurement, test, or examination. It can be used as a column name when converting a dataset from a vertical format to a horizontal format. The value in RETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). RETESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "FEV1", "FVC".
12 RE RETEST Name of Respiratory Test Char C111107 Synonym Qualifier Req Verbatim name of the test or examination used to obtain the measurement or finding. The value in RETEST cannot be longer than 40 characters. Examples: "Forced Expiratory Volume in 1 Second", "Forced Vital Capacity".
13 RE RECAT Category for Respiratory Test Char Grouping Qualifier Perm Used to categorize observations across subjects.
14 RE RESCAT Subcategory for Respiratory Test Char Grouping Qualifier Perm A further categorization.
15 RE REPOS Position of Subject During Observation Char C71148 Record Qualifier Perm Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING".
16 RE REORRES Result or Finding in Original Units Char Result Qualifier Exp Result of the procedure measurement or finding as originally received or collected.
17 RE REORRESU Original Units Char C71620 Variable Qualifier Perm Original units in which the data were collected. The unit for REORRES and REORREF.
18 RE REORREF Reference Result in Original Units Char Variable Qualifier Perm Reference result for continuous measurements in original units. Should be collected only for continuous results.
19 RE RESTRESC Character Result/Finding in Std Format Char Result Qualifier Exp Contains the result value for all findings, copied or derived from REORRES in a standard format or in standard units. RESTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in RESTRESN.
20 RE RESTRESN Numeric Result/Finding in Standard Units Num Result Qualifier Perm Used for continuous or numeric results or findings in standard format; copied in numeric format from RESTRESC. RESTRESN should store all numeric test results or findings.
21 RE RESTRESU Standard Units Char C71620 Variable Qualifier Perm Standardized unit used for RESTRESC, RESTRESN and RESTREFN.
22 RE RESTREFC Character Reference Result Char Variable Qualifier Perm Reference value for the result or finding copied or derived from --ORREF in a standard format.
23 RE RESTREFN Numeric Reference Result in Std Units Num Variable Qualifier Perm Reference result for continuous measurements in standard units. Should be populated only for continuous results.
24 RE RESTAT Completion Status Char C66789 Record Qualifier Perm Used to indicate that a test was not done or a measurement was not taken. Should be null if a result exists in REORRES.
25 RE REREASND Reason Not Done Char Record Qualifier Perm Describes why a measurement or test was not performed. Examples: "BROKEN EQUIPMENT", "SUBJECT REFUSED". Used in conjunction with RESTAT when value is "NOT DONE".
26 RE RELOC Location Used for the Measurement Char C74456 Record Qualifier Perm Anatomical location of the subject relevant to the collection of the measurement. Examples: "LUNG", "BRONCHUS".
27 RE RELAT Laterality Char C99073 Variable Qualifier Perm Side of the body used to collect measurement. Examples: "RIGHT", "LEFT".
28 RE REDIR Directionality Char C99074 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL".
29 RE REMETHOD Method of Test or Examination Char C85492 Record Qualifier Perm Method used to create the result.
30 RE RELOBXFL 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.
31 RE REBLFL Baseline Flag Char C66742 Record Qualifier Perm Indicator used to identify a baseline value. Should be Y or null. Note that REBLFL is retained for backward compatibility. The authoritative baseline flag for statistical analysis is in an ADaM dataset.
32 RE REDRVFL Derived Flag Char C66742 Record Qualifier Perm Used to indicate a derived record. Should be "Y" or null. Records that represent the average of other records, or that do not come from the CRF, or are not as originally collected or received are examples of records that would be derived for the submission datasets. If REDRVFL = "Y", then REORRES could be null, with RESTRESC and (if numeric) RESTRESN having the derived value.
33 RE REEVAL 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: "ADJUDICATION COMMITTEE", "INDEPENDENT ASSESSOR", "RADIOLOGIST".
34 RE REEVALID Evaluator Identifier Char C96777 Variable Qualifier Perm Used to distinguish multiple evaluators with the same role recorded in REEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2".
35 RE REREPNUM Repetition Number Num Record Qualifier Perm The instance number of a test that is repeated within a given time frame 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 pulmonary function.
36 RE VISITNUM Visit Number Num Timing Exp Clinical encounter number. Numeric version of VISIT, used for sorting.
37 RE VISIT Visit Name Char Timing Perm Protocol-defined description of a clinical encounter. May be used in addition to VISITNUM and/or VISITDY.
38 RE VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the visit based upon RFSTDTC in Demographics.
39 RE 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.
40 RE EPOCH Epoch Char C99079 Timing Perm Epoch associated with the date/time at which the assessment was made.
41 RE REDTC Date/Time of Collection Char ISO 8601 Timing Exp Date/time of procedure or test.
42 RE REDY Study Day of Visit/Collection/Exam Num Timing Perm Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
43 RE RETPT 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, such as time of last dose. See RETPTNUM and RETPTREF. Examples: "Start", "5 minutes post".
44 RE RETPTNUM Planned Time Point Number Num Timing Perm Numeric version of RETPT to aid in sorting.
45 RE REELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm Planned Elapsed time relative to a planned fixed reference (RETPTREF). Not a clock time or a date/time variable, but an interval, represented as ISO duration. Examples: "-PT15M" to represent 15 minutes prior to the reference time point indicated by RETPTREF, or "PT8H" to represent 8 hours after the reference time point represented by RETPTREF.
46 RE RETPTREF Time Point Reference Char Timing Perm Description of the fixed reference point referred to by REELTM, RETPTNUM, and RETPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".
47 RE RERFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time for a fixed reference time point defined by RETPTREF.