What Changes When the Site Is a Kitchen Table

Part of Decentralized Trials (DCT) Training: Foundations for Decentralized Conduct.

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

The requirements do not move

A decentralized trial is still a trial. Consent must be informed. Eligibility must be verified. Adverse events must be captured. Data must be attributable.

What changes is that you cannot see the participant, the room, or what they are actually doing. Every requirement still applies, and most of your usual evidence is gone.

What you lose, stated plainly

You cannot observe. A coordinator at a site notices that somebody looks unwell, or that a partner is answering for them. Down a video link you see a face and a wall.

You cannot control the setting. The lighting, the interruptions, who else is present.

You do not hold the product. It goes to a door, and somebody signs for it who may not be the participant.

You do not run the device. A wearable collects data you never touched, from a person you cannot watch.

So the record has to do more work

At a site, a great deal is implicit. Everyone knows the participant walked in and sat down.

Remotely, nothing is implicit. Who was present, how identity was confirmed, what was visible, what could not be assessed, and what you did about it all have to be written, because there is no room anybody could later describe.

The method does not outrank the assessment

This is the single most useful idea in decentralized conduct.

If a protocol requires an assessment and a remote method cannot deliver it, the assessment wins. You convert that visit to in-person or to a local provider. You do not accept a weaker version because the study is described as decentralized.

Decentralized is a choice made per visit, not a fixed property of a study.

What this course covers

Ten chapters following the work: running a remote visit, verifying identity, remote and electronic consent, connected devices, participant-entered data, safety escalation, home nursing, direct-to-participant shipping, and vendor oversight.

The last chapter is the largest part of the job and the least visible. Most of what happens in a decentralized trial is done by somebody you do not employ.