Another typical KQI in RbM would be “normality test”, which indicates whether data is normally distributed or skewed. The skewed data is often influenced by a systematic error, which shifts the bell-shaped distribution to one side or another (see below).
The advantage of KPIs, and KQIs is their comparability among trials and retrospectively. The KRIs are more useful for their predictability of the dangerous situations as taking the right actions at the right time can prevent unwanted consequences.
CAPA on practice
Summing up, all discussed instruments like KPIs, KRIs, KQIs in RbM aim at identifying, assessing, controlling, communicating and reviewing risks associated with your clinical trial during its lifecycle. This will facilitate making your trial safer for the patients, giving your trial management team full control over a trial and helping to flag any dangerous situations before they occur.
How you negotiate these situations, is up to you to decide.
 Sproull, Natalie L. (2002). “Hypothesis testing”. Handbook of Research Methods: A Guide for Practitioners and Students in the Social Science (2nd ed.). Lanham, MD: Scarecrow Press, Inc. pp. 49–64. ISBN 0-810-84486-9.
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