Wearable devices and sensor data: the CRC's role — Data Collection and Source Documentation

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The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.

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Fourteen million data points per participant -- and you did not create a single one

A participant enrolled in a cardiac safety study receives a small adhesive patch at the enrollment visit. The research coordinator peels the backing, places the patch on the participant's upper left chest per the device manual's instructions, confirms the green indicator light is blinking, and hands the participant a pre-paired smartphone that will relay data from the patch to the sponsor's cloud platform. Over the next 12 weeks, that patch will record a single-lead electrocardiogram 24 hours a day, seven days a week. The resulting dataset will contain approximately 14 million data points for this one participant.

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.