Unpacking the ‘Quality Box’: Measuring quality in clinical monitoring activities-what are the key determinants of quality in the practice of monitoring?

Your input and perspectives are greatly appreciated in this unpacking exercise!

There is on-going debate about the effectiveness and efficiency of different monitoring mechanisms (e.g. on-site monitoring, central statistical monitoring) and approaches (e.g. risk-based monitoring versus 100% data verification) in improving the quality and conduct of clinical trials. Quality in this field has been defined by the Clinical Trials Transformation Initiative (CTTI) (https://www.ctti-clinicaltrials.org) as the ‘the ability to effectively answer intended question about the benefits and risks of a medicinal product (therapeutic or diagnostic) or procedure, while assuring the protection of human subjects’.

When it comes to the practice of monitoring, research undertaken by CTTI (1) suggests that the major quality objectives are: 1) to ensure the integrity of the data generated in clinical trials, and thus the reliability of the results, and 2) to ensure that risks to participants are minimized and that they are treated ethically.

But how can we measure whether these quality objectives have been achieved-can specific performance indicators be identified to evaluate practice?

Then when it comes to the art of monitoring, what are the key characteristics or determinants of good quality?

1. Clinical Trials Transformation Initiative. Quality Objectives of Monitoring Workstream 2 Final Report Project: Effective and Efficient Monitoring as a Component of Quality in the Conduct of Clinical Trials: (2009, accessed 5th December 2012 https://www.ctti-clinicaltrials.org/website-administration/documents/WS2%20Final%20Report.pdf).