When You Cannot Assess What the Protocol Asks

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

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

Say so rather than approximate

A required assessment you cannot perform, are not certified on, or cannot complete on the day is recorded as not performed, with the reason.

The alternative is a value that looks like the assessment and is not.

Reasons that are legitimate and should be recorded

The participant declined. Equipment was unavailable. The participant was too unwell. You are not certified on the instrument. The window had passed.

Each is a different fact, and "not done" without a reason loses all of it.

A partial assessment is recorded as partial

Three of five components completed is three of five, not a whole assessment with an estimate for the rest.

Do not have somebody else's assessment recorded as yours

If a colleague performed it, the record names them. Signing for an assessment you did not make is a documentation integrity problem, not a formality.

Certification is specific and it expires

Protocol-specific scale certification lapses. Performing a certified assessment after your certification has expired invalidates it.

Check your own dates the way you check the delegation log.

Escalate a repeated inability

If an assessment is regularly not being done, that is a site problem with a cause: equipment, scheduling, training or an unrealistic visit design.

One instance is an event. A pattern is something the sponsor needs to hear.

Write it at the time

A reason reconstructed weeks later will be vague, and vagueness in a safety assessment is exactly what an inspector probes.