Risk-based monitoring

RISK-BASED MONITORING APPROACH

Risk Management is part of our philosophy. Identifying the major risks (Key Risk Indicators) and critical data is key to building a comprehensive, centralised and dynamic risk-based monitoring plan.

The components of Risk-Based Monitoring are broader than just focusing on the balance between on-site and remote activities.

COMPREHENSIVE

Package of measures among which on-site monitoring is only a portion
It encompasses data review and statistical analysis

CENTRALISED

Comparison of data at global results level and individual sites level
It emphasizes on remote data review and site management contacts

DYNAMIC

The monitoring planning process is iterative, ongoing, and based on the project needs determined by the analysis of objective and subjective indicators

3 categories of risk

Indicators are defined during the risk assessment and planning phase, in comparison with the standard of care and risk of GCP/GPE non-compliance. 3 categories of risk should be considered:

• PROTOCOL
• DATA
• SITE

Protocol and data-level risks determine the intensity, frequency, types, and timing of monitoring activities, whereas site-level risks account for timing, tasks and type of monitoring activities.

With this in mind, we adapt our monitoring guidelines to each project, in accordance with the critical parameters of the study, the early-warning signals, the specificities of safety monitoring. We also train our Clinical Research Assistants (CRAs), for each new study, to on-site/remote monitoring activities, to follow the corrective actions put in place, and, in a general way, to anticipate problems by providing sites with the necessary support. This last aspect is facilitated by the geographical location of our monitors, distributed throughout Europe, mainly on the outskirts of major cities.

In order to better manage potential risks, our project managers assess the needs of the investigation sites on a monthly basis and organise, or even modulate if necessary, the CRA visits to focus on the most sensitive sites, according to predefined factors. This assessment takes into account all the information shared in real time on ICTA CTMS via its i-SIT platform, and allows the project team to monitor in real-time investigation sites and patient data, and thus to cross-reference quality markers between monitoring activities and data management.

The best strategy for risk management primarily depends on the type of project, and results from a combination of the methodologies described above.

The different approaches of clinical trial monitoring can be used together for effective oversight and monitoring and for the protection of data integrity and patient safety.