Risk-Based Monitoring
Monitoring strategy that targets oversight resources to the highest-risk sites, processes, and data based on a documented risk assessment, replacing 100% source data verification.
Definition
Risk-Based Monitoring (RBM) is a clinical trial oversight approach that uses a documented risk assessment to direct monitoring resources to the trial elements (sites, processes, data points) most critical to subject safety and data integrity. Rather than performing 100% source data verification (SDV) at every site, sponsors combine centralized statistical monitoring (off-site analytics on EDC data), targeted on-site monitoring focused on critical data and processes, and remote source data review where feasible. The broader practice, Risk-Based Quality Management (RBQM), extends this approach to all quality oversight activities.What this means in practice
RBM became the default expectation under ICH E6(R2) addendum (2016) and is reinforced in E6(R3) (2023). For device IDE studies, sponsors implementing RBM must produce a documented risk assessment, defined Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs), trigger-based monitoring procedures, and centralized monitoring analytics. FDA bioresearch monitoring inspections increasingly evaluate RBM implementation depth.- •Declaring RBM without a documented risk assessment, the assessment is the foundation; without it, RBM is just reduced SDV.
- •Setting KRIs/QTLs without thresholds for action, KRIs that no one acts on add cost without benefit.
- •Cutting on-site visits to zero, RBM redistributes monitoring, it doesn't eliminate it.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsGood clinical practice for clinical investigations of medical devices.
Independent committee that periodically reviews accumulating safety and (sometimes) efficacy data during a trial.
A trial that uses telehealth, home-based assessments, wearables, and direct-to-patient logistics to reduce or eliminate site visits.
Software systems used to collect, manage, and report clinical trial data electronically, replacing paper case report forms.
Clinical Trials & Evidence
· From this learning pathTrial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Documented assessment of clinical data demonstrating EU MDR conformity for a device.
Any untoward medical occurrence in a subject, whether or not related to the device.
Small clinical study evaluating initial safety, usability, and design parameters of an investigational device.
Primary references
3 sources- 1
FDA Oversight of Clinical Investigations GuidanceVerifiedFDAfda.gov
- 2
ICH E6(R3) Good Clinical PracticeVerifiedICHich.org
- 3
ClinicalTrials.govVerifiedNIHclinicaltrials.gov
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