Conducting the Visit and Recording What You Saw
Part of Decentralized Trials (DCT) Training: Running a Remote Visit.
About 2 minutes. Free, in your language, no account needed.
Record what was observed, and how
The central discipline of remote conduct. At a site, "participant appeared well" is backed by a person in a room. Remotely it is backed by a video window.
So say which. "Observed by video: participant alert, speaking in full sentences, no visible distress" is honest and assessable. "Participant well" is not, because nobody later knows what you could actually see.
Name what you could not assess
A remote visit will usually leave something unassessed. That is normal and it must be visible.
"Peripheral edema not assessable by video" is a good record. Silence implies it was assessed and found normal.
Participant-reported is a different kind of data
A temperature the participant read to you from their own thermometer is participant-reported. A weight they read from their own scale is participant-reported.
Record it as such. It may be perfectly usable, and the person analyzing it needs to know what it is.
Interruptions and third parties belong in the record
If somebody else was present, or answered for the participant, or the call dropped twice, write it.
These affect how the visit should be read. A coordinator at a site would have noticed them and so would have everyone else in the room. Remotely, only you know.
Do not let the technology set the agenda
It is easy to spend a visit troubleshooting audio and reach the end having asked three of eleven questions.
Protect the clinical content. If the connection is poor, switch to phone and complete the assessments that a phone can support, then document the rest as not assessable.
Close the visit deliberately
Confirm what happens next, what they should watch for, and how to reach the team urgently.
At a site this happens naturally at the door. Remotely, the call ends and they are alone.