SEND RE specification

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 dosing group number.

Perm

Applicant-Defined Identifier

Char

Identifier

Applicant-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 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 applicant-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 applicant-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 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 duration

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 duration

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