Training That Is Not Optional

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

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

Being a good clinician is not protocol training

You may have treated this condition for fifteen years. This protocol has its own definitions, its own scales, its own thresholds and its own reporting rules.

Study-specific training is documented, dated, and checked first at inspection.

What is usually required

The protocol, read and documented as read, at the version in force.

GCP training, current. Most sponsors expect refresh on a cycle.

Protocol-specific assessments. If the study uses a rating scale, you may need certification on it, not just familiarity.

The investigator brochure, particularly the safety sections, because you will be attributing events against it.

Amendments need retraining

A substantial amendment changes what the protocol requires. Working to the previous version is a deviation even when you follow it exactly.

Check the version of the document you are reading. Sites keep superseded copies, and they look identical.

The investigator brochure is a clinical document

It is where the expected adverse reactions are listed. Attribution and expectedness both depend on it, and expectedness is a regulatory determination with reporting consequences.

If you have not read the current one, you cannot make those judgments properly.

Know the emergency procedures before you need them

Unblinding: who authorizes it, how it is done, and what must be recorded. Overdose and medication error handling. The 24-hour contact for medical questions.

Looking these up during an emergency is the wrong time.

Document the training when it happens

A training log completed months later from memory is a reconstruction, and it reads as one.

Say when you have not been trained

A protocol-specified assessment you have not been certified on is one you should not perform. That is an awkward sentence and a cheap one compared with the alternative.