The Risks People Miss

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

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

The register fills with the familiar

Slow recruitment, site underperformance, drug supply. Real risks, and the ones everybody lists. The dangerous ones are the risks that do not feel like project risks.

Single points of failure

One coordinator at a high-enrolling site. One person who understands the IRT configuration. One manufacturing batch covering the next eight months. Each is fine until it is not, and the failure is total rather than gradual.

Assumptions inherited from the protocol

The protocol assumed a visit window of three days, and the population is elderly and depends on family transport. The protocol assumed a laboratory sample processed within two hours, and the site's laboratory closes at five. These are conduct risks created at design time, and they are visible at feasibility if anyone asks.

The amendment nobody sequenced

A substantial amendment requires ethics and regulatory approval in every country, and they do not arrive together. For a period, different countries are running different protocol versions. That is normal and it is manageable, but only if somebody planned for it. Unplanned, it produces deviations that look like site errors.

The slow accumulation

Risks that do not announce themselves: data entry lag creeping up a few days a month, a query backlog growing steadily, a monitoring schedule slipping visit by visit. None of these is a crisis on the day you notice it, and all of them are expensive by the time they become one.

Trends belong in the risk review. A number that is acceptable today and has moved in the same direction for four months is a finding.