myCSG © |Area: SDTM| Concept: EG : ECG Test Results | Lesson: LCSG001 : ECG dataset Programming for study CSG001 |

 

Background
  • In some clinical trials, we may have to collect data about different parameters from electrocardiogram (ECG) and its interpretation
  • Some example data points are:
    • PR interval
    • ST interval
    • QT interval
    • QRS duration
    • RR interval
    • Interpretation
  • SDTM standard has a standard domain for capturing these findings - "ECG Test Results (EG)"
  • EG dataset belongs to Findings class and has an expected record structure of 'One record per finding or result per time point per visit per subject'

CV Physiology | Electrocardiogram (EKG, ECG)

What type of information is typically collected or presented?
  • Date of assessment
  • Test performed status
    • Yes
    • No 
      • Reason not performed
  • Short name of the test
  • Name of the test
  • Position of the subject when test was performed
  • Method of test or examination
  • Result
    • in original units
    • in standard units
  • Derived information
    • Baseline flag - when results of a test are collected over pre and post treatment period
 


Lesson description will be added soon
variable_namevariable_labelderivation
General Electrocardiogram information is collected in ecg dataset. So, this dataset becomes the base input dataset for creating SDTM.EG dataset. The information related to the tests performed are collected as variables in the input datasets. As the expected structure for SDTM EG 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 raw.ecg.STUDY
DOMAIN Domain Abbreviation Set to "EG"
USUBJID Unique Subject Identifier Concatenate STUDY and PT variable values using hyphen as separator
EGSEQ Sequence Number Sort the final dataset by USUBJID, EGCAT, EGTESTCD, EGDTC and set to 1 on the first record of the subject and increment by 1 on subsequent records.
EGTESTCD ECG Test or Examination Short Name Set to "HR" for the rows representing result from raw.ecg.HR_RAW
Set to "PR" for the rows representing result from raw.ecg.PR_RAW
Set to "QT" for the rows representing result from raw.ecg.QT_RAW
Set to "QRS" for the rows representing result from raw.ecg.QRS_RAW
Set to "QTC" for the rows representing result from raw.ecg.QTC_RAW
Set to "INTP" for the rows representing result from raw.ecg.EGINTP.
EGTEST ECG Test or Examination Name Set to "Heart Rate" when EGTESTCD="HR"
set to "PR Interval" when EGTESTCD="PR"
set to "QT Interval" when EGTESTCD="QT"
set to "QT Interval Corrected" when EGETSTCD="QTC"
set to "QRS Interval" when EGTESTCD="QRS"
set to "Interpretation" when EGTESTCD="INTP"
EGCAT Category for ECG Set to "ECG"
EGORRES Result or Finding in Original Units raw.ecg.HR_RAW for EGTESTCD="HR", raw.ecg.PR_RAW for EGTESTCD="PR", raw.ecg.QT_RAW for EGTESTCD="QT", raw.ecg.QTC_RAW for EGTESTCD="QTC", raw.ecg.QRS_RAW for EGTESTCD="QRS"; When raw.ecg.EGINTP in ("Abnormal Not Clinically Significant" "Abnormal Clinicall Significant") then set to "ABNORMAL" and when raw.ecg.EGINTP="Normal" then set to "NORMAL" for EGTESTCD="INTP"
EGORRESU Original Units Set to "msec" when EGTESTCD in ("PR" "QT" "QTC" "QRS"), set to "beats/min" when EGTESTCD="HR"
EGSTRESC Character Result/Finding in Std Format sdtm.eg.EGORRES
EGSTRESN Numeric Result/Finding in Standard Units Convert sdtm.eg.EGSTRESC to numeric value when EGTESTCD in ("HR" "PR" "QT" "QTC" "QRS")
EGSTRESU Standard Units sdtm.eg.EGORRESU
EGSTAT Completion Status Set to "NOT DONE" when sdtm.eg.EGORRES is null
EGMETHOD Method of Test or Examination raw.ecg.EGMETHOD
EGBLFL Baseline Flag Set to "Y" on the latest record with non-missing result on or prior to SDTM.DM.RFSTDTC per EGTESTCD.
VISITNUM Visit Number 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 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 Derive by comparing EGDTC 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.
EGDTC Date/Time of ECG Convert raw.ecg.EGDT_RAW to ISO 8601 format.
EGDY Study Day of ECG numeric(datepart(sdtm.eg.EGDTC))-numeric(datepart(sdtm.dm.RFSTDTC))+(numeric(datepart(sdtm.eg.EGDTC))>=numeric(datepart(sdtm.dm.RFSTDTC)))
EGCLSIG Clinically Significant For EGTESTCD="INTP", set to "N" when raw.ecg.EGINTP="Abnormal Not Clinically Significant"
set to "Y" when raw.ecg.EGINTP="Abnormal Clinically Significant"
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