Delegation, Training and Platform Access

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

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

The usual rules, plus one more

You must be delegated for your study tasks and trained for them, with both documented and dated before the work. That does not change.

Decentralized conduct adds a fourth thing: the systems. Your access to the telehealth platform, the eConsent system, the device portal and the ePRO dashboard is part of the record.

Access is evidence

System access logs show who saw what and when. That is useful and it is also a record you are inside.

An account shared between two coordinators makes every entry unattributable. It is quick, it feels harmless, and it destroys the audit trail for everything either person does.

Never use somebody else's login, and never lend yours.

Access must be removed too

When somebody leaves the study, their access should be withdrawn and the withdrawal recorded.

Active accounts for people no longer on the delegation log is one of the most common findings in decentralized studies, because removal is nobody's obvious job.

Training is platform-specific

Knowing how to take consent is not the same as knowing how this eConsent system records it. Knowing how to run a visit is not knowing where this platform stores the recording, or whether it makes one.

Study-specific system training must be documented like any other.

Know what the platform does without telling you

Some systems auto-save. Some time out and discard. Some record the session and some do not. Some notify the participant of changes and some do not.

These behaviors affect your record, and none of them are obvious from the screen. Find out before a visit, not during one.

When the platform fails mid-visit

Have the fallback agreed in advance: a phone number, a rescheduling rule, and a way to document what was completed before the connection dropped.

A visit half-completed and not documented is worse than one not attempted, because the record implies it happened.