Development↦Monitoring↦Montoring Strategy↦Risk-Based Monitoring
What is it? Why is it important?
Risk-Based Monitoring (RBM) requires that the strategy of monitoring is adapted based on the risk of the study. Not all studies carry the same risks. Thus, monitoring strategies can be adapted accordingly.
Adaptations may include:
- Monitoring frequency: low-risk studies require less monitoring
- Extent of monitoring: low-risk studies require less data and document checks (e.g. 20% of data versus 80%)
- Nature of monitoring with on-site versus Central Data Monitoring versus. High-risk studies may require more on-site monitoring than low-risk studies
The study SP-INV is responsible to identify risks of the study.
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RBM should focus on critical data, such as:
- Medical records that prove the existence of study participants
- IC documentation that provides evidence that all participants have agreed to participate in the study
- Data related to the primary endpoint (e.g. data on whether study treatment was successful)
- Safety documentation that demonstrates compliance with safety reporting procedures to EC and RA
- Follow-up of participants with safety issues (e.g. occurrence of an SAE)
What do I need to do?
As a SP-INV, define the monitoring strategy of your study. From a monitoring point of view, the strategy should be risk-based. As a helpful tool, use the SCTO RBM score calculator..
Assess risks-based on:
- Study risk category, type of intervention (e.g. ClinO, ClinO-MD), target population, study design (e.g. randomised, double-blind), data collection procedures, and particpant safety concerns
- System-level: Risks related to IT, SOPs, and infrastructure (e.g. work and storage space, access to patient rooms, labs, resources such as budget, available time, and qualified staff)
Define thresholds that will trigger measures to reduce risks. Based on risk, the monitoring strategy may be to adapt the number of planned monitoring visits accordingly
For more information refer to Study Quality and Risk in this Study Guide
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When defining the monitoring strategy of the study, consider the following aspects:
- Complexity of design (e.g. randomized, blinded, cross-over, pilot cohort)
- Data complexity (e.g. many variables, extensive eCRF)
- Study Risks (e.g. vulnerable participants, first-in-man study)
- Recruitment frequency (e.g. large numbers of participants are recruited within a short period of time)
- Number of participants (e.g. less than 20 versus several hundred)
- Number of participating sites (e.g. monocentric versus multicentric in Switzerland, international study)
- Existing safety data that requires increased surveillance
The CTU-RBM score calculator lists 22 potential study risks classified in 7 categories: participants, design, safety, intervention, management, data, and others.
Each of the following risk factors is evaluated on a 3-level scale (1 = low, 2 = medium, 3 = high):
- Impact
- Occurrence
- Detectability
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
External Links
- ADAMON – Risk-adapted monitoring
References
ICH GCP E6(R2) – see in particular guidelines
- 4.5 Protocol compliance
- 4.8 Informed consent of study participants
- 5.0 Quality management
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 5.8 Informed consent
- 5.2 Risk management
Swiss Law
ClinO – see in particular article
- Art. 19 - 20 Study categorisation
HRO – see in particular article
- Art. 7 Research categorisation