The coordinator will not transcribe any of those data points. The coordinator will not review the ECG waveforms for clinical abnormalities -- that is the cardiologist's role. The coordinator will not code, clean, or process the raw signal data. And yet, the coordinator's responsibilities for this wearable device dataset are substantial, specific, and consequential. If the participant removes the patch for three days because the adhesive irritates their skin and does not tell anyone, the data gap is invisible until someone reviews the compliance dashboard. If the smartphone battery dies and data transmission stops for 48 hours, the patch may continue recording locally -- but only if its onboard memory has not filled. If the patch falls off during a shower and the participant reattaches it upside down, the signal quality degrades in ways that are difficult to distinguish from a genuine arrhythmia.

This lesson covers the CRC's operational role with wearable devices and sensor data in clinical trials. It builds directly on the previous lesson's treatment of ePRO and eCOA, but addresses a fundamentally different data collection paradigm: passive, continuous measurement that occurs without the participant actively doing anything -- in contrast to ePRO, where the participant must consciously open an app and answer questions. That distinction matters because it changes everything about what the coordinator monitors, what can go wrong, and what the source documentation must capture.

The coordinator will not transcribe any of those data points. The coordinator will not review the ECG waveforms for clinical abnormalities -- that is the cardiologist's role. The coordinator will not code, clean, or process the raw signal data. And yet, the coordinator's responsibilities for this wearable device dataset are substantial, specific, and consequential. If the participant removes the patch for three days because the adhesive irritates their skin and does not tell anyone, the data gap is invisible until someone reviews the compliance dashboard. If the smartphone battery dies and data transmission stops for 48 hours, the patch may continue recording locally -- but only if its onboard memory has not filled. If the patch falls off during a shower and the participant reattaches it upside down, the signal quality degrades in ways that are difficult to distinguish from a genuine arrhythmia.

This lesson covers the CRC's operational role with wearable devices and sensor data in clinical trials. It builds directly on the previous lesson's treatment of ePRO and eCOA, but addresses a fundamentally different data collection paradigm: passive, continuous measurement that occurs without the participant actively doing anything -- in contrast to ePRO, where the participant must consciously open an app and answer questions. That distinction matters because it changes everything about what the coordinator monitors, what can go wrong, and what the source documentation must capture.