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
Slide 1 / 5| Source | Examples |
|---|---|
| Central laboratory | Chemistry, hematology, PK samples |
| ECG core lab | Intervals (QT/QTc), interpretations |
| Imaging core lab | Tumor measurements, MRI readings |
| ePRO/eCOA | Diaries, questionnaires on devices |
| IRT | Randomization, kit dispensing |
| Wearables/sensors | Activity, heart rate |