“Can you please distinguish the difference between QTLs and risk indicator/thresholds? How does your interpretation align/differ from recent TransCelerate paper? “
ICH GCP Ref: 5.0.4 ; 5.0.7
Quality Tolerance Limits (QTLs) are set at a study/protocol level and are typically a sub-set of the KRIs that are being used to look at site quality. The intent of the QTL is to determine if either subject well-being/safety or data integrity are being put at risk to such a level that the overall study could be in jeopardy. The tolerance limits or thresholds set at a site level are likely to be different, possibly multiple, each with different actions e.g. watch and wait, vs act. The QTL should be set to a level that allows proactive recovery steps to be implemented and should be set based on experience and expertise (medical and statistical) and the QTL is likely to be specific to the study or therapy area/indication. Common indicators where QTLs are implemented are Subject Consent Errors (particularly re-consent), Protocol Deviations (Particularly edibility), AE Rates, AEs/SAEs of Special Interest, Subject Visits Out of Window, others specific to the study e.g. Incomplete/missing end point data such as images.I think our definition is similar to the recently published TransCelerate paper.