Queries, Monitoring and Being Checked

Part of Sub-Investigator (SUBI) Training: Contemporaneous Source Documentation.

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

Being queried is the system working

A monitor comparing the CRF against the source and finding a discrepancy is doing exactly what they are there for.

Queries are not criticism, and treating them as criticism makes sites slower to answer, which delays the study.

Answer from the source, not from memory

Go back to the record. If the source says something different from what you remember, the source is the answer, or the source is wrong and needs a documented correction.

Never change the source to match the CRF

The CRF is derived from the source. A source amended to agree with a transcription is falsification, even when the transcription was right.

Correct the CRF instead.

A query you disagree with is answered, not ignored

Explain the clinical reasoning. A monitor querying an attribution may not have the context you had.

An unanswered query stays open and turns up at database lock.

Persistent queries usually mean something

The same query recurring across participants is a site practice, a misunderstood definition or an ambiguous CRF.

Raise the pattern rather than answering each instance. The pattern is fixable.

Prepare for a monitoring visit by having nothing to prepare

Records complete as you go, laboratory reports reviewed and signed, queries answered, and consent forms filed.

A site that tidies before a visit produces documents created after the fact, which is a worse finding than whatever was untidy.

Your availability is part of the visit

Monitors need the investigator for things a coordinator cannot answer: medical judgments, attributions, and unreviewed results.

Being unavailable pushes those into a follow-up letter, and unresolved findings accumulate.