What is it? Why is it important?

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

What do I need to do?

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

In order to ensure 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).

Where can I get help?

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


ICH GCP E6(R2) – see in particular guideline

  • 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



  • ClinO - Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • GCP – Good Clinical Practice
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organisation for Standardisation
  • SP-INV – Sponsor-Investigator
Development ↦ Monitoring ↦ Montoring Strategy ↦ Aim

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 ↦ Aim

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