The CDASHIG EG domain includes ECG data, including the position of the subject; method of evaluation; all cycle measurements; and all findings from the ECG, including an overall interpretation, if collected.
In the Central Reading scenario, results are captured directly by an electronic device and transmitted separately or read by a central vendor, rather than recorded on the CRF. The accession number and date collected on the CRF can be used as an aid in reconciliation of the electronic data.
If performing multiple ECGs on the same day, the planned time point and ECG time would also need to be collected. Additional Method and Position values are available in Controlled Terminology.
EG CENTRAL eCRF Package