| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
| DOMAIN | Domain Abbreviation | Char | RE | Identifier | Two-character abbreviation for the domain. | Req |
| 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 |
| SPDEVID | Applicant Device Identifier | Char |
| Identifier | Applicant-defined identifier for a device. | Perm |
| RESEQ | Sequence Number | Num |
| Identifier | 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. | Req |
| REGRPID | Group ID | Char |
| Identifier | Optional group identifier, used to link together a block of related records within a subject in a domain. | Perm |
| REREFID | Reference ID | Char |
| Identifier | Optional internal or external procedure identifier. |
Perm |
| Applicant-Defined Identifier | Char |
| Identifier | Applicant-defined identifier. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. | Perm |
| RELNKID | 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 |
| RELNKGRP | Link Group | Char |
| Identifier | Identifier used to link related records across domains. This will usually be a many-to-one relationship. | Perm |
| RETESTCD | Short Name of Respiratory Test | Char | (RETESTCD) | Topic | 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". | Req |
| RETEST | Name of Respiratory Test | Char | (RETEST) | Synonym Qualifier | 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". | Req |
| RECAT | Category for Respiratory Test | Char |
| Grouping Qualifier | Used to categorize observations across subjects. | Perm |
| RESCAT | Subcategory for Respiratory Test | Char |
| Grouping Qualifier | A further categorization. | Perm |
| REPOS | Position of Subject During Observation | Char | (POSITION) | Record Qualifier | Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING". | Perm |
| REORRES | Result or Finding in Original Units | Char |
| Result Qualifier | Result of the procedure measurement or finding as originally received or collected. | Exp |
| REORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. The unit for REORRES and REORREF. | Perm |
| REORREF | Reference Result in Original Units | Char |
| Variable Qualifier | Reference result for continuous measurements in original units. Should be collected only for continuous results. | Perm |
| RESTRESC | Character Result/Finding in Std Format | Char |
| Result Qualifier | 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. | Exp |
| RESTRESN | 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 RESTRESC. RESTRESN should store all numeric test results or findings. | Perm |
| RESTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized unit used for RESTRESC, RESTRESN and RESTREFN. | Perm |
| RESTREFC | Character Reference Result | Char |
| Variable Qualifier | Reference value for the result or finding copied or derived from --ORREF in a standard format. | Perm |
| RESTREFN | Numeric Reference Result in Std Units | Num |
| Variable Qualifier | Reference result for continuous measurements in standard units. Should be populated only for continuous results. | Perm |
| RESTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that a test was not done or a measurement was not taken. Should be null if a result exists in REORRES. | Perm |
| REREASND | Reason Not Done | Char |
| Record Qualifier | Describes why a measurement or test was not performed. Examples: "BROKEN EQUIPMENT", "SUBJECT REFUSED". Used in conjunction with RESTAT when value is "NOT DONE". | Perm |
| RELOC | Location Used for the Measurement | Char | (LOC) | Record Qualifier | Anatomical location of the subject relevant to the collection of the measurement. Examples: "LUNG", "BRONCHUS". | Perm |
| RELAT | Laterality | Char | (LAT) | Variable Qualifier | Side of the body used to collect measurement. Examples: "RIGHT", "LEFT". | Perm |
| REDIR | Directionality | Char | (DIR) | Variable Qualifier | Qualifier for anatomical location or specimen further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL". | Perm |
| REMETHOD | Method of Test or Examination | Char | (METHOD) | Record Qualifier | Method used to create the result. | Perm |
| RELOBXFL | 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 |
| REEVAL | 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: "ADJUDICATION COMMITTEE", "INDEPENDENT ASSESSOR", "RADIOLOGIST". | Perm |
| REEVALID | Evaluator Identifier | Char | (MEDEVAL) | Variable Qualifier | Used to distinguish multiple evaluators with the same role recorded in REEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2". | Perm |
| REREPNUM | Repetition Number | Num |
| Record Qualifier | 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. | Perm |
| VISITNUM | Visit Number | Num |
| Timing | - An assigned numeric identifier that aligns to the chronological order of an encounter.
- Numeric version of VISIT, used for sorting.
| Exp |
| VISIT | Visit Name | Char |
| Timing | - The label for a protocol-defined encounter.
- May be used in addition to VISITNUM and/or VISITDY.
| Perm |
| VISITDY | Planned Study Day of Visit | Num |
| Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | Perm |
| 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 |
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the date/time at which the assessment was made. | Perm |
| REDTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Date/time of procedure or test. | Exp |
| REDY | Study Day of Visit/Collection/Exam | Num |
| Timing | Actual study day of visit/collection/exam expressed in integer days relative to the applicant-defined RFSTDTC in Demographics. | Perm |
| RETPT | 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, such as time of last dose. See RETPTNUM and RETPTREF. Examples: "Start", "5 minutes post". | Perm |
| RETPTNUM | Planned Time Point Number | Num |
| Timing | Numeric version of RETPT to aid in sorting. | Perm |
| REELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | 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. | Perm |
| RETPTREF | Time Point Reference | Char |
| Timing | Description of the fixed reference point referred to by REELTM, RETPTNUM, and RETPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL". | Perm |
| RERFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/time for a fixed reference time point defined by RETPTREF. | Perm |