What is it? Why is it important?

Monitoring 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.

More

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 of study design (e.g. randomized, blinded, placebo, cross-over)
  • Large numbers of recruited participants

What do I need to do?

Familiarise yourself with 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
  • Monitor’s responsibilities
  • Monitoring procedures
  • Monitoring report
  • Monitoring plan

In order to ensure GCP knowledge and compliance, the study SP-INV is required to have adequate documented GCP training.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guidelines

  • 4.5 Protocol compliance
  • 5.18 Monitoring activities

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. 19 - 20 Study categorisation

HRO – see in particular article

  • Art. 7 Research categorisation
Abbreviations
  • CTU – Clinical Trials Unit
  • GCP – Good Clinical Practice
  • SP-INV – Sponsor-Investigator
Development ↦ Monitoring ↦ Montoring Strategy ↦ Aim
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Development ↦ Monitoring ↦ Montoring Strategy ↦ Aim

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