Working When the PI Is Unavailable

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

About 1 minutes. Free, in your language, no account needed.

Absence is normal and it is planned for

Principal investigators take leave, attend conferences and get ill. A well-run study covers it and the cover is documented.

Know who is covering

There should be a named individual, appropriately delegated, with the PI's duties for that period, and it should be documented before the absence.

"Whoever is around" is not cover. Reserved decisions cannot be made by somebody who is not delegated for them.

Cover does not expand your own delegation

If you are not delegated for a reserved decision, an absent PI does not authorize you to make it. It authorizes you to reach the person who is delegated.

Emergency care never waits

If a participant needs treatment now, treat them. Document, and report as soon as you can reach somebody.

Non-urgent decisions can wait, and should be tracked

An eligibility sign-off for a participant screening next week is not urgent. Note it, hold it, and make sure it is actually done rather than assumed.

Things lost during an absence are usually lost because nobody kept a list.

Escalate a structural gap

If the site repeatedly has no reachable PI, that is a study management problem affecting participant safety.

Raise it with the sponsor. Absorbing it locally keeps it invisible to the people who can fix it, and it puts you in the position of making decisions that are not yours.

Record the route you used

"PI on leave; covering investigator Dr Okafor contacted 16:05, confirmed continuation" shows a properly authorized decision.

Without that, the record shows you deciding alone.