Statistical monitoring

[chrisQA]

Coordinating large multi centre CTIMPs can be difficult to monitor on many levels and I was wondering if anyone has any examples of where they have used statistical monitoring i.e. identifying Key Risk Indiciators and putting in place triggers for increasing monitoring at certain sites etc...

Any examples or comments would be kindly appreciated?

Many thanks

[Nicolemen]

I have an example of statistical monitoring in a multicenter clinical trial of a new drug for the treatment of a chronic disease.


Adherence to the protocol was taken as the key risk indicator (KRI). During monitoring, the following was carried out:


- Data collection (such as missed visits, unfilled forms, or deviations from dosing schedules are collected from each trial site throughout the study period)


Statistical analysis (control charts or Bayesian approaches, frequency and patterns of protocol deviations were applied).


- Setting triggers (based on historical data and predefined thresholds).


- Action plan (additional monitoring measures were initiated, such as site visits, data audits or retraining sessions for site staff).


- Continuous monitoring (performed continuously throughout the trial to detect abnormalities and prompt intervention to support protocol adherence and data quality).