Device Accountability and Getting Them Back

Part of Decentralized Trials (DCT) Training: Connected Devices and Wearables.

About 2 minutes. Free, in your language, no account needed.

A device is study equipment, and it is in someone's home

Each one has a serial number, an assignment to a participant, a deployment date, and eventually a return.

That is a custody chain like any other, and it is the one most often kept badly, because a wearable feels like a consumer object rather than trial equipment.

Record the assignment properly

Which device, which serial, to which participant, on what date, and who sent it.

"A wearable was issued" is not accountability. When a device turns out to have a firmware fault affecting a batch, the serial number is how you find out who is affected.

Replacements need the same discipline

A device swapped mid-study creates two records for one participant, and the data from each must be attributable to the right one.

This is where device data quietly becomes unattributable: a replacement sent quickly, with no record of which serial produced which period of data.

Plan the return at the start

Prepaid packaging, a clear instruction, and a reminder. Participants are willing; they are also busy, and a device with no return route stays in a drawer.

Chase, but gently and on a schedule

Devices become harder to recover with time. A polite reminder at two weeks recovers far more than an awkward call at three months.

Record the attempts, as with any other contact.

Unreturned devices are documented, not forgotten

If a device is not coming back, record that and the attempts made. It affects accountability and it may affect whether the data from it can be verified.

Wipe and reassign deliberately

A device passed to a new participant without being cleared can carry the previous participant's data. Know the vendor's process, confirm it happened, and record it.

That is a personal data obligation, not housekeeping.