myCSG © |Area: SDTM| Concept: VS : Vital Signs | Lesson: LCSG001 : Vital Signs Programming for study CSG001 |
Creating more than one observation from a single observation of input dataset
Lesson description will be added soon
Lesson description will be added soon
VITALS : Vital Signs
| Question | Response |
|---|---|
| Date Performed [VSDT_RAW] |
|
| Systolic Blood Pressure (mmHg) [SYSBP_RAW] |
|
| Diastolic Blood Pressure (mmHg) [DIABP_RAW] |
|
| Blood Pressure Position [POS] |
Supine Standing Sitting |
| Heart Rate (beats/min) [HR_RAW] |
|
| Respiratory Rate (breaths/min) [RESP_RAW] |
|
| Temperature [TEMP_RAW] |
|
| Temperature Unit [TEMPU] |
Celsius Fahrenheit |
| Temperature Location [TEMPLOC] |
|
PHYSMEAS : Physical Measurements
| Question | Response |
|---|---|
| Date Performed [PMDT_RAW] |
|
| Height [HEIGHT_RAW] |
|
| Height Unit [HEIGHTU] |
Inches Centimeters |
| Weight [WEIGHT_RAW] |
|
| Weight Unit [WEIGHTU] |
Kilogram Pound |
| SUPP | variable_name | variable_label | type | general_comment | form_vitals | form_physmeas |
|---|---|---|---|---|---|---|
| _ | General | _isb | Vital Signs information is collected in two different datasets, vitals and physmeas. So, these two datasets become the base input datasets for creating SDTM.VS dataset. The information related to the tests performed are collected as variables in the input datasets. As the expected structure for SDTM VS domain is one record per subject per test per timepoint, we need to transform the test results and other dependent variables from horizontal to vertical structure. | |||
| _ | STUDYID | Study Identifier | Char | For the recods coming form raw.physmeas: raw.physmeas.STUDY. | For the records coming from raw.vitals: raw.vitals.STUDY | |
| _ | DOMAIN | Domain Abbreviation | Char | Assign as "VS" | ||
| _ | USUBJID | Unique Subject Identifier | Char | Concatenate STUDY and PT variable values using hyphen as separator | ||
| _ | VSSEQ | Sequence Number | Num | Sort the final dataset by USUBJID, VSCAT, VSTESTCD, VSDTC and set to 1 on the first record of the subject and increment by 1 on subsequent records. | ||
| _ | VSTESTCD | Vital Signs Test Short Name | Char | Results for different tests are collected in separate varaibles in raw. To fit SDTM findings structure, rows are created to hold the results of different tests in a single result variable and VSTESTCD is created to identify each test with a short name. Set to "SYSBP" for raw.vitals.SYSBP_RAW set to "DIABP" for raw.vitals.DIABP_RAW set to "HR" for raw.vitals.HR_RAW set to "RESP" for raw.vitals.RESP_RAW, set to "TEMP" for raw.vitals.TEMP_RAW |
Results for different tests are collected in separate varaibles in raw. To fit SDTM findings structure, rows are created to hold the results of different tests in a single result variable and VSTESTCD is created to identify each test with a short name. Set to "HEIGHT" for raw.physmeas.HEIGHT_RAW set to "WEIGHT" for raw.physmeas.WEIGHT_RAW |
|
| _ | VSTEST | Vital Signs Test Name | Char | Set to "Height" when VSTESTCD="HEIGHT", set to "Weight" when VSTESTCD="WEIGHT", set to "Systolic Blood Pressure" when VSTESTCD="SYSBP", set to "Diastolic Blood Pressure" when VSTESTCD="DIABP", set to "Heart Rate" when VSTESTCD="HR", set to "Respiratory Rate" when VSTESTCD="RESP", set to "Temperature" when VSTESTCD="TEMP". | ||
| _ | VSCAT | Category for Vital Signs | Char | Set to "VITAL SIGNS" | Set to "PHYSICAL MEASUREMENTS" | |
| _ | VSPOS | Vital Signs Position of Subject | Char | Set to raw.vitals.POS when VSTESTCD in ("SYSBP" "DIABP") after converting to standard controlled terminology | ||
| _ | VSORRES | Result or Finding in Original Units | Char | Set to raw.vitals.SYSBP_RAW when VSTESTCD="SYSBP", set to raw.vitals.DIABP_RAW when VSTESTCD="DIABP", set to raw.vitals.HR_RAW when VSTESTCD="HR", set to raw.vitals.RESP_RAW when VSTESTCD="RESP'", set to raw.vitals.TEMP_RAW when VSTESTCD="TEMP". | Set to raw.physmeas.HEIGHT_RAW when VSTESTCD="HEIGHT", set to physmeas.WEIGHT_RAW when VSTESTCD="WEIGHT", | |
| _ | VSORRESU | Original Units | Char | Set to "mmHg" when VSTESTCD in ("SYSBP", "DIABP"), set to "beats/min" when VSTESTCD="HR", set to "breaths/min" when VSTESTCD="RESP", set to "C" when VSTESTCD="TEMP" and raw.vitals.TEMPU="Celsius", set to "F" when VSTESTCD="TEMP" and raw.vitals.TEMPU="Fahrenheit". | On the records where VSORRES is not null: Set to "cm" when VSTESTCD="HEIGHT" and raw.physmeas.HEIGHTU="Centimeters". Set to "in" when VSTESTCD="HEIGHT" and raw.physmeas.HEIGHTU="Inches". set to "kg" when VSTESTCD="WEIGHT" and raw.physmeas.WEIGHTU="Kilogram". set to "lb" when VSTESTCD="WEIGHT" and raw.physmeas.WEIGHTU="Pound". |
|
| _ | VSSTRESC | Character Result/Finding in Std Format | Char | Convert VSSTRESN to character format. | ||
| _ | VSSTRESN | Numeric Result/Finding in Standard Units | Num | Part A) For the records of the tests (VSTESTCD in ("TEMP") ) where original unit collected is different than standard units: If VSTESTCD="TEMP" and VSORRESU="Fahrenheit" then VSSTRESN=(VSORRES-32)*5/9 and rounded to two decimals Part B) For the records of all tests where original unit is same same as collected unit: Convert VSORRES to numeric format. |
Part A) For the records of the tests (VSTESTCD in ("WEIGHT" "HEIGHT" ) ) where original unit collected is different than standard units: If VSTESTCD="HEIGHT" and VSORRESU="Inches" then apply a multiplier of 2.54 to the numeric value of VSORRES. If VSTESTCD="WEIGHT" and VSORRESU="Pound" then apply a multiplier of 2.2 to the numeric value of VSORRES. Part B) For the records of all tests where original unit is same same as collected unit: Convert VSORRES to numeric format. |
|
| _ | VSSTRESU | Standard Units | Char | Set to "mmHg" when VSTESTCD in ("SYSBP", "DIABP") Set to "beats/min" when VSTESTCD="HR" Set to "breaths/min" when VSTESTCD="RESP" Set to "C" where VSTESTCD="TEMP". |
Set to "kg" when VSTESTCD in ("WEIGHT") Set to "cm" when VSTESTCD="HEIGHT". |
|
| _ | VSSTAT | Completion Status | Char | Set to "NOT DONE" when VSORRES is null and VSSTRESC is null. | ||
| _ | VSREASND | Reason Not Performed | Char | Set to "Not collected" when VS.VSSTAT="NOT DONE" | Set to "Not collected" when VS.VSSTAT="NOT DONE" | |
| _ | VSLOC | Location of Vital Signs Measurement | Char | raw.vitals.TEMPLOC when VSTESTCD="TEMP" after converting to standard controlled terminology | ||
| _ | VSBLFL | Baseline Flag | Char | Set to "Y" on the latest record with non-missing result on or prior to SDTM.DM.RFSTDTC per VSTESTCD of each subject. | ||
| _ | VISITNUM | Visit Number | Num | Set to 1 when VISIT="SCREENING" Else when VISIT contains "WEEK" then add 100 to the week number (that is, WEEK 1 will have a VISITNUM of 101) Else when VISIT contains "FOLLOW-UP" then add 200 to the numeric portion of the VISIT For Unscheduled visits, add the unscheduled visitnumber as a two digit decimal to the previous scheduled visit number. (For example, a third unscheduled visit after VISITNUM 102 will be formatted as 102.03) |
||
| _ | VISIT | Visit Name | Char | Set to "SCREENING" when FOLDER="SCR" Else when FOLDER contains "Week" then convert FOLDER to uppercase Else when FOLDER contains "FU" then replace "FU" with "FOLLOW-UP" Unscheduled visits (FOLDER contains "UNS_") will be remapped based the previous scheduled VISIT when sorted by VSDTC For each unscheduled visit present after a scheduled visit, concatenate the word 'UNSCHEDULED' to the previous scheduled visit followed by the number of the unscheduled padded with a leading zero. (For example, a third unscheduled visit after "WEEK 2" will be formatted as 'WEEK 2 UNSCHEDULED 03") |
||
| _ | EPOCH | Epoch | Char | Derive by comparing VSDTC with the sdtm.se.SESTDTC and sdtm.se.SEENDTC of each element of a subject and assign the epoch based on the sdtm.se.EPOCH of the element in which each event start date falls. | ||
| _ | VSDTC | Date/Time of Measurements | Char | Convert raw.physmeas.PMDT_RAW and raw.vitals.VSDT_RAW respectively for the respective parameters coming from raw.physmeas and raw.vitals and convert into ISO 8601 format. | ||
| _ | VSDY | Study Day of Vital Signs | Num | numeric(datepart(VSDTC))-numeric(datepart(DM.RSTDTC))+(numeric(datepart(VSDTC))>=numeric(datepart(DM.RFSTDTC))) |
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