The Role You Have Just Taken On

Part of Sub-Investigator (SUBI) Training: What a Sub-Investigator Is.

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

You are already a clinician. This is the other half

You know how to assess a patient, recognize a deterioration and make a treatment decision. None of that changes.

What changes is that your clinical judgment is now also trial data, and it is read by people who were not in the room and who will read it years later.

What a sub-investigator is, formally

A member of the site team delegated by the principal investigator to perform specified trial-related duties that require medical judgment.

The word doing the work in that sentence is specified. You are authorized for named tasks, not for the trial in general.

The principal investigator remains responsible

Delegating a task does not transfer accountability for the conduct of the trial. The PI is answerable for what you do under their delegation.

That is not a comment on your competence. It is how the regulatory structure is built, and it is why escalation is part of your job rather than an admission of difficulty.

Two duties at once, and they can pull apart

Your duty of care to the patient in front of you, and your obligations to the protocol.

Most of the time they agree. Where they do not, the patient's safety comes first, always, and the departure is documented and reported. That is not a loophole; it is written into the standard.

What makes trial work different

Everything is written. A judgment you would normally make and act on now has to be recorded in a way a stranger can follow.

Timing is fixed. Assessments happen in windows, and a clinically reasonable delay can be a protocol deviation.

Attribution matters. Whether an event is related to the study intervention is a judgment somebody will rely on.

What this course covers

Ten chapters: delegated authority, consent you take yourself, eligibility, clinical assessment inside a protocol, adverse events and attribution, source documentation, escalation, working with the site team, and your own record.

The chapter on escalation is the one that matters most, and the one people find hardest.