An Eligibility Call at the Margin

Part of Sub-Investigator (SUBI) Training: Eligibility and the Protocol.

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

Criteria are thresholds, not guidance

An inclusion criterion of eGFR above 45 means above 45. A participant at 44 does not meet it.

This feels rigid when the difference is clinically meaningless. The rigidity is the point: every site applying the same rule is what makes the populations comparable.

Enrolling outside criteria is a serious deviation

It affects the participant's safety assessment, the integrity of the dataset, and often the analysis population.

It is among the deviations sponsors treat most seriously, and it is almost always discovered.

Waivers are not a site decision

Some sponsors operate a documented waiver process. Many do not, and the trend is against them.

Where one exists, it is granted in advance and in writing by the sponsor. A coordinator's recollection of a phone call is not a waiver.

Check the value that applies

Criteria usually specify a window: within 28 days, at screening, at baseline. A qualifying result from four months ago may not qualify.

Repeat testing is permitted in some protocols and not others. Read the rule rather than assuming the better value counts.

Document the assessment, not just the conclusion

"Eligible" is a conclusion. A record showing each criterion assessed against a dated source value is evidence.

Where a criterion required judgment, say what you judged and why.

Borderline means consult

A participant sitting exactly on a threshold, or whose history is ambiguous, is a conversation with the PI and often with the medical monitor.

Asking is quick. Reversing an enrollment is not.

The participant is not served by a stretched criterion

It is tempting to see enrollment as offering access. A participant enrolled outside criteria may face risks the protocol's safety monitoring was not designed for.