Who Does the Work You Are Accountable For

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

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

Most of it is done by people outside your organization

A home nursing agency draws bloods. A courier delivers product. A device vendor collects and transmits readings. A telehealth platform hosts the visit.

The investigator remains responsible for the conduct of the trial. Delegating the task does not delegate the accountability.

Know the chain before you need it

For each activity, you should be able to say who performs it, who trained them, who holds their records, and who you call when it goes wrong.

Finding that out during an incident is how hours are lost. Knowing it in advance is most of what oversight means in practice.

Vendors are not interchangeable

A device vendor's obligations differ from a courier's. A home nursing agency employs clinicians who make judgments; a courier does not.

Where a vendor makes a judgment that affects participant safety or data, their training and qualification are part of your trial record, not just their internal business.

Data provenance is the question that matters

For any value in the dataset, you should be able to say where it came from, who or what produced it, and whether it was changed on the way.

A blood pressure typed by a home nurse, a step count from a wrist device and a symptom score entered by the participant have three different provenances. Treating them as one kind of number is the error decentralized trials make most often.

You are the one who notices

A vendor reports what their system is configured to report. They do not know your protocol, your endpoints, or which visit was critical.

Nobody else is positioned to see that a device stopped transmitting three days before a scheduled assessment. That noticing is the job.

Escalate early, as always

A vendor problem reported the day you see it is a managed event. The same gap found at database lock is a set of missing data points nobody can recover.