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.


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:


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


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

External Links

  • ADAMON – Risk-adapted monitoring


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



  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • CTU-RBM – CTU-Risk Based Monitoring
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organisation for Standardisation
  • IT – Information Technology
  • RA – Regulatory Authorities SAE
  • RBM – Risk Based Monitoring
  • SAE – Serious Adverse Event
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor-Investigator
Development ↦ Monitoring ↦ Montoring Strategy ↦ Risk-Based Monitoring

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Development ↦ Monitoring ↦ Montoring Strategy ↦ Risk-Based Monitoring

Please note: the Easy-GCS tool is currently under construction.