Japan CCCIDM SMIS: Electrocardiogram (ECG)

This example shows ECG results where only the overall interpretation was collected (EGTEST = Interpretation). This reflects whether the ECG was Normal or Abnormal in the variable EGORRES and the standardized variable EGSTRESC. Note that VISITNUM (visit number) is an expected variable in the EG domain, so it is shown here. Be aware that excluding this variable will flag a warning when validating datasets for conformance to SDTM rules using validation software, but this may never be an issue or the error could be explained if necessary. The example shows one normal and one abnormal ECG interpretation.

Includes Item Number 17 - Abnormality on ECG, represented as an ECG finding rather than a medical history event as in Example 1a.