What to Escalate and When

Part of Sub-Investigator (SUBI) Training: Escalating to the Principal Investigator.

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

Escalation is a duty, not a last resort

The PI is accountable for the conduct of the trial. They cannot exercise that accountability over things they are not told.

Escalating is you doing your job, not failing at it.

Escalate immediately

A serious adverse event. A death. A suspected unexpected serious adverse reaction. A safety signal across more than one participant. A participant enrolled who did not meet criteria. A consent problem. A suspected data integrity issue.

Escalate promptly

A protocol deviation. A dose given incorrectly. An assessment missed outside the window. A participant who cannot be contacted. A decision the protocol reserves to the PI.

Escalate for a decision

Anything the protocol reserves, and anything at the edge of your delegated authority.

A two-minute call before a decision is a consultation. The same call afterward is a report about a deviation.

Escalate uncertainty

If you are unsure whether something matters, that is itself the reason to raise it. Judging importance requires study-wide context you do not have.

The cost of an unnecessary escalation is a few minutes.

Give the facts before the interpretation

What happened, when, to whom, what you did, what you are unsure about. Then your assessment, labeled as an assessment.

Document that you escalated

Who, when, by what route, and what they decided. An escalation that is not recorded did not happen, from the record's point of view.

If you cannot reach them

Use the backup route in the protocol. For an emergency, act clinically and report as soon as you can.

A participant is never left waiting on a decision because an escalation route did not answer.