| 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] |
|
| SUPP | VARIABLE_NAME | VARIABLE_LABEL | TYPE | GENERAL_COMMENT | FORM_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. |