Raising a Concern About the Conduct of the Trial

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

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

The harder kind of escalation

Not a clinical question, but a concern that something is being done wrongly. Data that does not look right. Consent taken after a procedure. Pressure to enroll somebody who does not qualify.

These are rarer and they are the ones that matter most.

Start with the assumption of error

Most apparent misconduct is a mistake, a misunderstanding or a pressured shortcut. Ask before concluding.

A question phrased as a question usually gets an explanation, and the explanation is usually mundane.

Write down what you observed

Dates, participant identifiers, what you saw, and who you asked. Contemporaneously.

A concern raised months later from memory is far weaker, and the detail that would have resolved it is gone.

Know the routes that exist

The principal investigator first, in most cases. Beyond that: the sponsor's medical monitor, the sponsor's quality function, the ethics committee, and your own institution's research governance office.

If the concern is about the PI, the PI is not the route.

Reporting obligations are not optional

Serious breaches of GCP or the protocol have defined reporting requirements in most jurisdictions, and they sit with the sponsor once told.

Deciding not to pass something on because it might cause trouble is a decision you are not entitled to make.

Participant safety overrides everything else

If participants are at risk, that is escalated immediately and by whatever route works.

You are protected, and it is still hard

Most institutions and sponsors have protections for people who raise concerns in good faith. Knowing they exist does not make the conversation comfortable, and the discomfort is not a reason.