By: Patrick Smith
Adoption of risk-based monitoring practices has grown in the industry of clinical trials at a slow but steady pace over the last decade. For many looking to make this transition, however, the question of where to begin poses a challenging question. From the standpoint of technology use, this entry point is centralized monitoring. In this short blog post we will examine some of the steps and operational challenges of onboarding central monitoring, and how Datatrak’s eClinical platform can assist.
Central monitoring is all about access to data and the tools to draw insights from it. By funneling broad and useful insights into a central monitoring team, sponsors and CROs are able to identify issues with site and data management performance early enough to maximize the effect of mitigation strategies. To do this, they need access to clear signals drawn from both operational and clinical data.
Datatrak has three primary routes through which these signals are reported:
In our EDC, we capture important metrics like aging and average time to closure for queries broken down by site, or summarized within regions of trial conduct. Our Averages report can detail the average amount of time each site takes to move between tracked metadata statuses like Visit Date -> Data Entry, Data Entry -> Signed, or Data Reviewed -> Database Locked. Anything not explicitly captured by our standard reports, can be easily assembled into one using our powerful and flexible Ad-Hoc reporting utility.
Our CTMS examines data from a more operational standpoint. Here we are able to track similar performance metrics related to individual CRA’s, or aging metrics for site and study action items. The CTMS also evaluates trends in enrollment statistics by site and study, and compares them against current planned enrollment projections.
This is a small sampling of the reporting capabilities of these two systems but, in addition to these native reporting capabilities, our Business Intelligence (BI) tool which layers over our entire enterprise suite enables advanced reporting and analytics to be performed on the data living within the CTMS. Our BI layer enables the ingestion of data from third parties outside our ecosystem, and, perhaps most importantly, produces reports that can be served to users working within the CTMS platform itself.
In order to take action on the signals coming into a central monitoring operation, the EDC and/or CTMS in use must also enable efficient remote monitoring. Remote monitoring implies simply that monitoring is being performed over the web rather than on-site. This means that in addition to the tools required to capture site visit reports in a central location, the systems involved must support effective communication between the central monitoring team and those personnel more directly involved with or working at the investigative sites.
Remote Monitoring Tools
Our CTMS provides users with a host of tools for designing and adhering to a centralized monitoring strategy. Site visit report templates can be built, deployed, and completed within the system using tools that automate their population. Within Datatrak’s ecosystem, data does not have to move between the EDC and CTMS, it is a truly unified platform. Which means that when a central monitor needs to jump into the EDC to review query data or patient information that is not being captured in the CTMS, they are only a single click away from seeing that data. No additional logins, no integration required. Our EDC allows site users to attach documentation directly to eCRFs for monitor review, and provides monitors with tools needed for batch data cleaning and query resolution. All data cleaning activities performed by the monitor within the EDC can then be automatically populated into their site visit reports.
When it comes time to communicate the findings of a central monitor or to review and approve visit reports, we provide several avenues for this exchange of information. Our entire CTMS has a querying functionality that can be used to redline monitoring reports during the approval process. As mentioned above, we also provide tools for capturing Site and Study Action Items that can be pulled automatically into the corresponding trip report. Use of our Communications Manager allows the sending of emails and documentation to site or study personnel and to track when responses arrive. At the level of the EDC, our intuitive querying tools allow monitors to easily communicate issues to sites directly in the system, and to track their resolution.
Risk-based monitoring, while daunting, is a worthwhile initiative to pursue given the right resources are in place. Fortunately for all those interested, the first step is quite attainable with the right technology in place. Implementing remote central monitoring provides some of the operational efficiencies that RBM promises, and requires only mild deviation from what is already common practice for those working within an EDC platform. If you’d like to hear more about how Datatrak supports this shift in practice, we’re available at any time for a short demonstration.