The Edge of Your Own Authority

Part of Sub-Investigator (SUBI) Training: Working Within Your Delegated Authority.

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

Knowing where it ends is the skill

Most sub-investigator errors are not wrong judgments. They are correct judgments made about something that was not theirs to decide.

Reserved decisions

Some determinations are usually reserved to the principal investigator, and the protocol will say which.

Final eligibility sign-off. Dose modifications outside protocol-defined rules. Discontinuing a participant. Unblinding. Causality on a serious adverse event, in many studies.

If the protocol reserves it and you make it, the decision is invalid even when it is right.

Ask before, not after

A two-minute call before the decision is a consultation. The same call after is an escalation about a deviation.

The difference costs nothing in advance and a great deal afterward.

The exception is emergency care

If a participant needs immediate treatment, you treat them. You do not wait for authorization to act clinically.

Then you tell the PI as soon as practicable, and the departure is documented and reported. The standard is explicit that participant safety takes precedence.

Document that you sought authority

"Discussed with Dr Ahmed at 14:20; eligibility confirmed on the basis of the repeat creatinine" shows the decision was made by the person entitled to make it.

Without that line, the record shows you deciding.

Do not let workload move the line

A busy clinic with an absent PI is exactly when the line gets crossed, and the reason always sounds sensible at the time.

If the PI is genuinely unavailable and a reserved decision is needed, that is a study management problem to raise, not a gap for you to fill quietly.

Your own scope of practice still applies

Delegation cannot authorize something outside your professional registration or competence. A delegation log entry is not a license to practice beyond your scope.