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 application or submissions involving the product. | Req |
RESEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req |
REGRPID | Group Identifier | Char |
| Identifier | Used to tie together a block of related records in a single domain for a subject and can be used to support relationships within the domain and between domains using RELREC. This is not the treatment dosing group number. | Perm |
| SponsorApplicant-Defined Identifier | Char |
| Identifier | SponsorApplicant-defined reference identifier. | Perm |
RETESTCD | Test Short Name | Char | (SRETSTCD) | Topic | Short name of the measurement, test, or examination described in RETEST. It can be used as a column name when converting a dataset from a vertical 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: RESPRATE, TIDALVOL, MV. | Req |
RETEST | Test Name | Char | (SRETST) | Synonym Qualifier | Long name for RETESTCD. The value in RETEST cannot be longer than 40 characters. Examples: Respiratory Rate, Tidal Volume, Minute Volume. | Req |
REPOS | Position of Subject During Test | Char | (POSITION) | Record Qualifier | Position of the subject during the measurement or examination, If the subject is restrained, populate with the position (example SITTING or STANDING); otherwise, populate with UNCONSTRAINED. | Exp |
REORRES | Result or Findings as Collected | Char |
| Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp |
REORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Exp |
RESTRESC | Standardized Result in Character Format | Char |
| Result Qualifier | Contains the result value for all findings, copied or derived from REORRES in a standard format or 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 | Standardized Result in Numeric Format | Num |
| Result Qualifier | Used for continuous or numeric results or findings in standard format; contains the numeric form of RESTRESC. RESTRESN should store all numeric test results or findings. | Exp |
RESTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for RESTRESC and RESTRESN. | Exp |
RESTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in REORRES. | Perm |
REREASND | Reason Not Done | Char |
| Record Qualifier | Describes why RESTAT is NOT DONE, such as BROKEN EQUIPMENT. | Perm |
REMETHOD | Method of Test | Char |
| Record Qualifier | Method of the test or examination. Examples: Whole body plethysmograph, Head-out plethysmograph, Invasive. | Exp |
RECSTATE | Consciousness State | Char | (CSTATE) | Record Qualifier | Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS. | Exp |
REBLFL | Baseline Flag | Char | (NY) | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor applicant defined. | Exp |
REDRVFL | Derived Flag | Char | (NY) | Record Qualifier | Used to indicate a derived record. The value should be Y or null. | Perm |
REEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm |
REREASEX | Reason for Exclusion | Char |
| Record Qualifier | The reason the result should be excluded from all calculations. Used only when REEXCLFL is Y. | Perm |
REUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of the performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm |
REDTC | Date/Time of Respiratory Measurement | Char | ISO 8601 datetime or interval | Timing | Date/Time of respiratory data collection, in ISO 8601 format. For measurements related to a continuous evaluation interval, REDTC should be used to indicate the start date/time of that interval. | Exp |
REENDTC | End Date/Time of Respiratory Measurement | Char | ISO 8601 datetime or interval | Timing | Date/Time of end of the respiratory evaluation interval, in ISO 8601 format. Should be populated when REDTC represents the start date/time of a continuous evaluation interval. | Perm |
REDY | Study Day of Respiratory Measurement | Num |
| Timing | Study day of respiratory data collection, in integer days. For measurements related to a continuous evaluation interval, REDY can be used to indicate start day of that interval. The algorithm for calculations must be relative to the sponsorapplicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
REENDY | End Study Day of Respiratory Measurement | Num |
| Timing | Study day of the respiratory data collection, in integer days. Can be populated when REDY represents the start day of a continuous evaluation interval. The algorithm for calculations must be relative to the sponsorapplicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
RENOMDY | Nominal Study Day for Tabulations | Num |
| Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp |
RENOMLBL | Label for Nominal Study Day | Char |
| Timing | A label for a given value of RENOMDY as presented in the study report. Examples: Pretreatment, Week 4, Day 28. | Perm |
RETPT | Planned Time Point Name | Char |
| Timing | Text description of time when respiratory data should be collected. 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: Predose, 1 Hour Postdose. | Exp |
RETPTNUM | Planned Time Point Number | Num |
| Timing | Numerical version of RETPT to aid in sorting. | Exp |
REELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time (in ISO 8601 format) relative to a fixed time point reference (RETPTREF). This variable is useful where there are repetitive measures. 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 RETPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by RETPTREF. | Exp |
RETPTREF | Time Point Reference | Char |
| Timing | Name of the fixed reference point referred to by REELTM, if used for RETPTNUM, and RETPT. It is recommended that RETPTREF be as descriptive as possible so the reference time point can be inferred without looking at others variables. Example: DAY 1 FIRST DOSE. | Exp |
RERFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/Time of the reference time point, RETPTREF. | Perm |
REEVLINT | Evaluation Interval | Char | ISO 8601 datetime duration or interval | Timing | Length of evaluation interval in ISO 8601 duration format. Used in place of RESTINT and REENINT when RETPTREF is not available. | Perm |
RESTINT | Planned Start of Assessment Interval | Char | ISO 8601 datetime or intervalduration | Timing | Planned start of an assessment interval relative to Time Point Reference (RETPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT1H. | Exp |
REENINT | Planned End of Assessment Interval | Char | ISO 8601 datetime or intervalduration | Timing | Planned end of an assessment interval relative to Time Point Reference (RETPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT2H. | Exp |