myCSG © |Area: SDTM| Concept: RE : Respiratory System Findings | Lesson: L101 : Respiratory System Findings - FVC, FEV |

  • Complete key programming of RE domain
  • Programming includes
    • creation of tests using arrays
    • Derivation of --LOBXFL as per SDTM IG 3.3
    • Manually assigning units using arrays
    • Study day creation
    • --SEQ variable creation
    • And other general SDTM variables of RE domain

RESP : Respiratory System Findings
Question Response
Date Collected
[REDAT_RAW]

Forced Expiratory Volume in 1 second (L)
[FEV1]

Forced Vital Capacity (L)
[FVC]

Percent Predicted FEV1 (%)
[FEV1PP]

Percent Predicted Forced Vital Capacity (%)
[FVCPP]




SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_RESP
_ STUDYID Study Identifier Char Populate as 'statschoice'
_ DOMAIN Domain Abbreviation Char Populate as 'RE'
_ USUBJID Unique Subject Identifier Char Concatenate the value of STUDYID variable to SUBJECT variable with a hyphen in between.
_ RESEQ Sequence Number Num Sort the records by USUBJID, RETESTCD, REDTC and set to 1 on the first record for each subject, and increment by 1 for each subsequent record within the subject
_ RETESTCD Short Name of Respiratory Test Char The responses to each question item is collected in a separate variable. We need to transform the data such that we a create a row for each question
Create a record with RETESTCD=FEV1 to store the result from FEV1.
Create a record with RETESTCD=FVC to store the result from FVC.
Create a record with RETESTCD=FEV1PP to store the result from FEV1PP.
Create a record with RETESTCD=FVCPP to store the result from FVCPP.
_ RETEST Name of Respiratory Test Char Populate as 'Forced Expiratory Volume in 1 Second' when RETESTCD=FEV1.
Populate as 'Forced Vital Capacity' when RETESTCD=FVC.
Populate as 'Percent Predicted FEV1' when RETESTCD=FEV1PP.
Populate as 'Percent Predicted Forced Vital Capacity' when RETESTCD=FVCPP.
_ REORRES Result or Finding in Original Units Char Populate using FEV1 when creating row for RETESTCD=FEV1.
Populate using FVC when creating row for RETESTCD=FVC.
Populate using FEV1PP when creating row for RETESTCD=FEV1PP.
Populate using FVCPP when creating row for RETESTCD=FVCPP.
_ REORRESU Original Units Char Populate as "L" for RETESTCD=FEV1.
Populate as "L" for RETESTCD=FVC.
Populate as "%" for RETESTCD=FEV1PP.
Populate as "%" RETESTCD=FVCPP.
_ RESTRESC Character Result/Finding in Std Format Char Populate with the values from REORRES
_ RESTRESN Numeric Result/Finding in Standard Units Num Convert RE.RESTRESC values to numeric where applicable.
_ RESTRESU Standard Units Char Populate with the values from REORRESU
_ RELOBXFL Last Observation Before Exposure Flag Char Populate as "Y" on the latest record on or before RFXSTDTC per RETESTCD within a subject.
_ VISITNUM Visit Number Num Populate with the value from FOLDERSEQ
_ VISIT Visit Name Char Populate with the value from FOLDERNAME
_ REDTC Date/Time of Collection Char Populate using REDAT_RAW after converting to ISO8601 format.
_ REDY Study Day of Visit/Collection/Exam Num Populate using RE.REDTC and DM.RFSTDTC. If REDTC is on or after RFSTDTC then populate with the resulting value of REDTC-RFSTDTC+1. Else if REDTC is before RFSTDTC then populate with the resulting value of REDTC-RFSTDTC.
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