Your Easy Guide to Clinical Studies

The monitoring strategy should be risk-based. This means that the extent of monitoring activities should be adapted according to expected study risks (e.g. study complexity, inclusion of vulnerable participants, experience of site study team).

Monitoring activities should be supervised by an experienced professional.

 

The extent of study monitoring required is defined by inherent study risks, such as:

• Higher-risk studies (e.g. category B or C versus A)
• Inclusion of vulnerable population (e.g. children or adolescents, patients without capacity, pregnant women, participants with legal guardians)
• Complexity and nature of the study design (e.g. randomized, blinded studies, placebo studies, cross-over)
• Large numbers of recruited participants

As a SP-INV and monitor familiarise yourself with ICH-GCP, which gives detailed guidance on how to organize and implement the monitoring of your study, including:

• Purpose
• Selection and qualification of monitors
• Extent and nature of monitoring (e.g. on-site, central data monioring)
• Monitor’s responsibilities 
• Monitoring report
• Monitoring plan

In order to ensure ICH-GCP knowledge and compliance, the study SP-INV is required to have adequate documented GCP training (e.g. based on country specific GCP training requirements).

References

ICH GCP E6(R3) – see in particular guideline

• Glossary: definition monitoring
• 3.11.4 Monitoring
• 3.10.1.3 Risk control

ICH E8 – see in particular guideline

• 6.13 Data management – centralized monitoring
• 6.2.1 Safety monitoring

ISO 14155 Medical Device – see in particular section (access liable to costs)

• 6.7 Monitoring plan
• 9.2.4 Monitoring

Swiss Law

ClinO – see in particular article

• Art. 2b Definition of intervention
• Art. 19 - 20 Study categorisation

ClinO-MD – see in particular article

• Art. 6 Categorisation of clinical investigation
• Art. 6a Categorisation of performance studies

HRO – see in particular article

• Art. 3a Definition of research
• Art. 7 Research categorisation

 

Documents

• Risk-Based Monitoring (RBM) Score Calculator