Risk Is About What the Trial Is For

Part of Clinical Project Management (PM) Training: Finding the Risk That Matters.

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

Not everything that can go wrong matters equally

ICH E6(R3) asks for a risk-proportionate approach: identify what matters to participant safety and to the reliability of the results, and put the effort there.

That means some things are allowed to be imperfect. A misspelled site address is an error. An unverifiable primary endpoint is a different kind of thing entirely.

Critical to quality

The useful discipline is to name, before the trial starts, the factors without which the trial cannot answer its question or protect its participants. Typically:

Eligibility. Enrolling the wrong population makes the result unusable regardless of everything else.

The primary endpoint. How it is measured, by whom, and whether it is verifiable.

Informed consent. Whether it happened properly, and whether that can be demonstrated.

Safety reporting. Whether events are recognized and reported inside the clock.

Randomization and blinding. Whether allocation concealment held.

Investigational product accountability. Whether the right participant got the right product.

Everything else is managed, but not at the same intensity.

Where risk actually lives

Risk lives at the joins: between the site and the laboratory, between the CRO and the sponsor, between the protocol and the amendment, between the system and the person entering data. Activities inside one team's control tend to be done well. Handovers are where things fall.

Write it down before you need it

A risk assessment produced at the start, reviewed when something changes, is a working document. One produced to satisfy a checklist and never reopened is an artifact. An inspector can tell the difference by looking at whether it has been updated.