Inspection Readiness Without a Site

Part of Decentralized Trials (DCT) Training: Vendor Oversight and Data Provenance.

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

An inspector can still follow one participant

The traceability walk works here too. They pick a participant and follow them: consent, identity verification, each visit, each device, each shipment, each assessment.

If that path holds without a gap, most of the inspection is answered.

What is specific to decentralized conduct

System access. Who had it, when, and whether it was removed on time.

Consent version control. Which version each participant signed, and when.

Device assignment. Serial numbers, dates, replacements and returns.

Vendor oversight. Not the contracts, the evidence of checking.

Data provenance. Being able to say where a given value came from.

Do the walk yourself

Pick a participant at random and follow them through the records alone. Every gap you find this way is one an inspector will not.

This is worth doing quarterly, not annually. Decentralized records degrade faster because so many of them live in somebody else's system.

Know how to retrieve third-party records

An inspector asking for a device audit trail or an eConsent log does not accept "the vendor holds it".

Know how to export it, confirm you still can, and keep copies of anything a contract does not guarantee you will always have access to.

Records outlive contracts

When a vendor relationship ends, their data does not stop being your study record. Retention runs for years, sometimes decades.

Confirm what happens to your data at contract end before you need to know.

Do not reconstruct before an inspection

The same rule as anywhere. Records created after the fact are usually identifiable and they raise a question about everything else.

Why this matters beyond compliance

Decentralized trials exist so that people who could never reach a site can take part. That is a real widening of who gets to be in research.

It only counts if their data is as good as everybody else's. The whole of this course is about making sure that it is.