“What’s the current status on establishing a widely recognised risk assessment tool for clinical monitoring? I have the impression countries are individually setting up their tools as of how to evaluate risk criteria on the basis of available literature, but there’s no harmonised approach globally, yet. “
ICH GCP Ref: 5.0.1 ; 5.0.2 ; 5.0.3 ; 5.0.4 ; 5.18.1
There is no harmonized approach, and I am not sure there ever will be …
We are starting to see best practice process emerge for risk assessment and evaluation, that is being accepted by the main agencies, in the sense it has not been challenged during inspection. Similarly for clinical monitoring, I think the question is referring to a standard tool for risk detection as part of centralized monitoring. Some industry organizations such as MCC and TransCelerate have set out common data to review centrally across all trials, but risk, to a greater or lesser extent, depending on the trial design, will always be specific to the trial, so it is unlikely to get to the point of being ‘one size fits all’.
However, standards are emerging and as above, we do have examples of central monitoring plans and systems, such as OPRA, being used in studies that have been subject to inspection. What the agencies are looking for is a traceable process, that you have identified what is critical, assessed the risks, and tailored the study mgmt. plans to address those risks, some of which may include centralized monitoring techniques.