The key to effective Risk-Based Monitoring (RBM) is data – having essential information in your hands in a timely fashion.
Interactive Response Technology (IRT/IVR/IWR), which long ago had its start as a ‘randomization platform’ for clinical trials, is now a powerful tool-of-choice for subject and drug supply management, yielding data that can and should be leveraged as RBM support for clinical studies.
Good RBM enables study CRAs/PMs to monitor, without leaving their desks, the status of key project variables – i.e., variables that indicate potential risks that might require an enhanced response, like scheduling a site visit, focusing additional site training, or feeding back to decision makers issues and potential issues in study conduct.
Because Sites need to use the IRT in real-time fashion to assign subjects to treatment groups and provide them with their study drug at each visit (unlike the delayed data entry that can occur with EDC, for example), IRTs serve as an ‘early warning’ tool for important status information for the study overall and by Site. For example:
• Status of enrollment performance; number of subjects screened, randomized
• Gender distributions, age distributions, stratification distributions
• Cross-subject status of visits/activities completed
• Number and reasons for early withdrawals
• Number and type of protocol deviations –e.g., number of visits out of window
• Status of Site inventories and resupply algorithms; ability to predict and tweak the latter to ensure busy sites are stocked while underperforming sites are not receiving wasted drug
• Status of kits; damaged, temperature excursion, mis-administered, lost, expiring
Veracity Logic works with RBM applications to bring IRT insights like these into the RBM data-display mix.
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