When a Remote Visit Cannot Deliver the Assessment

Part of Decentralized Trials (DCT) Training: Running a Remote Visit.

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

The assessment governs, not the method

If the protocol requires an assessment and the remote method cannot produce it, the visit converts. To in-person, to a local provider, or to a home nursing visit.

This is not an escalation or an admission of failure. It is the design working as intended.

Recognize it early

Usually you can tell before the visit. A physical examination, an ECG, a timed walk test or anything requiring palpation will not happen down a video link.

Where it becomes difficult is the middle case: an assessment that could be done remotely, badly.

A weaker version is not the assessment

A participant describing a rash is not a skin examination. A participant counting their own pulse is not a measured heart rate.

Accepting the weaker version and recording it as the assessment puts a value in the dataset that looks like the real thing and is not. That is worse than a missing value, because a gap is visible and a wrong number is not.

What to do instead

Record what was actually obtained and label it accurately. Flag that the protocol-required assessment was not performed. Arrange the route that can deliver it.

Then report the deviation if the window will be missed.

The participant's convenience is not the deciding factor

Decentralized trials exist partly to reduce burden, and that is a real good. It does not override the protocol.

A participant who would rather not travel is a reason to find another route, not a reason to accept an assessment that cannot be made.

Document the decision, including the reasoning

"Visit 4 converted to in-person: protocol requires cardiac auscultation, not deliverable by video. Participant scheduled at site 14 March, inside window."

That record shows a person applying the protocol. It is also the paragraph that prevents the same question being asked at every subsequent visit.