One of the hottest topics in the clinical trials industry today is the transition to Risk Based Monitoring (RBM) (see Guidance for Industry: Oversight of Clinical Investigations_ A Risk-Based Approach to Monitoring; and ICH E6 R2). RBM includes the addition of a new ‘centralized monitoring’ function which focuses on risk within and across sites and even across projects, data that is then bundled to inform CRA activities.
But the industry is in transition: the vast majority of clinical trials are still not integrated with RBM processes. Project Managers and CRAs must still rely on IRT and EDC platforms to accomplish the kind of ‘pre-RBM’ remote monitoring within a project that mitigates risk and helps determine where site visits are needed and the level/type of SDV activities required.
The actionable intelligence found in the IRT is the earliest data available for risk assessment. At a recent industry conference it was estimated that data arrives in the EDC an average of 10-11 days after a site visit! Contrast that with the IRT, which focuses on Subject Management and Drug Supply Management. In the IRT, visit data are required to be entered in real time in order for subject IDs, randomization, or drug dispensation activities to be performed. On average, IRT data is reliably available a week or more before EDC data.
This means that CRAs, Lead CRAs and others in the monitoring mix (e.g., Clinical Trial Assistants who help with CRA-related administrative tasks) – as well as Project Managers – will have access to IRT data, either by direct access to the system or by reports and notifications generated from the system immediately or in near real-time.
Companies that provide IRT services on a ‘seat license’ basis may contribute to reducing the number of team members with direct access to the IRT, relying instead on second level data roundups (something that may or may not distress a CRA depending on their role – some may prefer direct access, others, like full-time road warriors, may prefer being fed information by others). Companies, like Veracity Logic, that do not limit access by seat, may enable more CRAs to monitor IRT data directly, and at their own pace.
Here are some examples of the actionable intelligence provided by IRTs ‘at a glance’:
- Higher than average number of missing, mis-administered, or damaged kits at a site
- A pattern of temperature excursions
- Inventory shortages/excesses that may indicate a problem with a site’s resupply algorithm
- Protocol deviations --- for example, system alerts for next activities that are out of visit window
- Unblinding histories and authorizations
- Fraud analysis – tabular displays and audit trails with date/time/user stamps provide quick insight into odd patterns, hinting at a need for further analysis
- Rollup reports that keep easy tabs on number screen failures and early withdrawals at a site
- Accountability data that hints of issues with compliance
- Shipping delays and abnormalities that may require process intervention
- All notifications/messages that have occurred for a given site since first-patient-in can be made available to the CRA within the system at any time, no matter when they take over the site. This enables a new monitor to minimize risk by remaining current on all site issues that have gone before.
IRT systems that enable easy ad hoc reporting to analyze risk indicators further add another layer of pre-RBM actionable intelligence from early on in your clinical trial.
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