What is an automated clinical alert? Automated clinical alerts continuously monitor study data and send alerts and notifications to clinical trial project team members based on specific study, country, site or subject performance criteria to help boost clinical study monitoring and improve quality management.
As clinical studies have increased in complexity, manual reviews have become impractical and inefficient for managing and tracking quality metrics in near real-time. Study teams can benefit from applying technology that provides automated alerts, gives a safety net of continuous oversight and replaces time-consuming manual tracking of study metrics. By catching emerging risks or issues as early as possible, study teams are able to implement corrective or preventive actions proactively, before any serious impact occurs.
Learn about a few of these alerts that can be integrated into study execution to complement risk-based quality management (RBQM) and increase the efficiencies of clinical trial managers, project managers and clinical research associates (CRAs).
1. Alerts for reaching Quality Tolerance Limits (QTLs)
If a critical threshold in a study is crossed without warning, study teams have lost precious mitigation time to take action to prevent impact to subject safety or integrity of trial results. Alerts for quality tolerance limits (QTLs) are based on secondary limits, so that teams get a warning in advance before it’s too late. This allows teams to take the necessary steps so they’re not in danger of missing data that could affect the power of the results or affect subject safety. Study teams need to be aware when secondary or graduated limits are crossed so they can perform mitigation as soon as possible.
2. Alerts related to data quality and missing data
Missing data or poor data quality can significantly impact the success of a trial. To avoid it, study teams need automated alerts to drive accountability for data quality. If the number of missing pages or outstanding queries reaches beyond the acceptable threshold, teams need to be informed in order to gain control of data collection.
With automated alerting in place, study teams can continuously be on top of data cleaning, proactively making sure that the database lock will happen on time. Automated alerts can also inform study teams about certain data quality issues before they are uncovered by manual central review.
3. Alerts for managing monitoring
Monitoring alerts can help study teams manage their monitoring strategies more effectively, especially for adaptive or volume-based strategies. Instead of manual data tracking, automated alerts can provide triggers for monitoring visits based on site milestones, patient events or monitoring workload backlog. This helps the study team manage their monitoring resources in an effective and efficient manner.
4. Subject activity alerts
Alerts can be used to inform study teams about important aspects of the subject recruitment activity. These alerts can help teams deal with subject management concerns such as: subject recruitment caps; highlighting sites with a high number of screen failures or withdrawn patients; or early identification of potential lost to follow-up patients across a study.
5. Alerts tracking process compliance and due dates
While alerts are helpful to get near real-time information about study events, they are also equally important to ensure study actions are being completed and are completed on time. For example, a team may identify an issue or an action, but then forget to resolve it within specified time. Due date alerts provide a reminder to resolve these in a timely manner.
Similar to due date alerts, process compliance alerts help to determine if steps in a process are completed in a consistent manner. These alerts aren’t solely site-specific, as they can also track operational items – like ensuring future monitoring visit dates are entered into a clinical trial management system – so the study team can reliably forecast monitoring activities as part of study management.
6. Organizational/operational management alerts
At an organization and operational level, action alerts help to facilitate governance and oversight activities by tracking data entry and ensuring timely updates.
The management of COVID-19 databases is a recent example of the value of these alerts. We have set up a database to track all studies and sites across its portfolio; the data included the open/closed status of each site to determine if patients and CRAs could visit. Action alerts were used to track whether site status was being updated in a timely manner to ensure the latest information was available. As a result, teams could track and follow up to ensure site status was being updated in time and monitoring activities could be planned appropriately.
Before using this alert, a lot of hours were being spent on manual review and follow-up. Now, these resources are able to complete more value-add activities as part of the recovery – focusing on the big picture and strategy enhanced by RBQM processes and technology.
Beyond driving decision making and allowing study teams to work more productively, learn how clinical alerts can be managed and integrated into RBQM processes to bring greater efficiency to clinical trial execution. Watch the on-demand webinar: How to Optimize Data Management Workflow with RBQM Concepts.
Gayle Keenan has over 25 years of experience in clinical research working in clinical operations, project management and central monitoring. Currently she is a associate director responsible for implementation and adoption of risk-based monitoring technologies and processes..