Guided Notes

External Data & Reconciliation

Central labs, ECG, imaging, ePRO and IRT data — data transfer specifications, file formats and loads, reconciling external data against EDC, and handling mismatches.

External data sources

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SourceExamples
Central laboratoryChemistry, hematology, PK samples
ECG core labIntervals (QT/QTc), interpretations
Imaging core labTumor measurements, MRI readings
ePRO/eCOADiaries, questionnaires on devices
IRTRandomization, kit dispensing
Wearables/sensorsActivity, heart rate