Laboratory Results and Clinical Significance

Part of Sub-Investigator (SUBI) Training: Clinical Assessment in a Trial.

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

Someone has to decide what an abnormal result means

Trial laboratory reports flag values outside the reference range. Many are of no clinical consequence, and a few matter a great deal.

Judging which is a sub-investigator's job, and it is usually a documented one.

Clinically significant has consequences

In most protocols, an abnormal result judged clinically significant becomes an adverse event with everything that follows: severity, causality, reporting and follow-up.

Marking a result not clinically significant is therefore a decision, not an administrative tick.

Look at the participant, not only the number

A potassium of 3.2 in an asymptomatic participant on a stable diuretic is different from the same value with new palpitations.

The judgment is clinical, which is exactly why it is delegated to a clinician.

Consider the trend, not only the threshold

A creatinine that has doubled while remaining inside the reference range may matter more than a stable value just outside it.

A single flagged result is a snapshot. The series is the finding.

Ask whether the sample explains it

Hemolysis raises potassium. A delayed sample raises it too. A wildly implausible result is often a sample problem.

Repeating before acting is often right, and the original result still belongs in the record.

Review promptly

A result reviewed three weeks later is a safety signal that went unread for three weeks. Some results need action the same day.

Know which thresholds require urgent action in your study.

Sign and date the review

An unreviewed laboratory report in a participant file is a standard inspection finding, and it is one of the easiest to avoid.