What is it? Why is it important?

The aim of monitoring is to verify or notice particular things.


As in daily medical practice, activities are monitored and inconsistencies are corrected. These processes are especially important when conducting a study.


The purpose of study monitoring is to verify that:

  • Participants’ safety, rights, and well-being are protected
  • The quality and integrity of study data is guaranteed
  • A study is conducted in compliance with the study protocol, GCP, and applicable laws and regulations.

What do I need to do?

As a SP-INV select a study monitor who:

  • Is appropriately trained and has experience in study monitoring
  • Has relevant scientific knowledge
  • Is thoroughly familiar with the study protocol, GCP, study IMP/IMD, including applicable laws and regulations


The study SP-INV is responsible to appoint a qualified study monitor. The SP-INV can delegate monitoring tasks to a contractor/CRO/local CTU, but remains responsible for the quality of any delegated services.

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

  • 9.2.4 Monitoring (access liable to costs)

Swiss Law

HRA – see in particular

  • Art. 10c Good practice guidelines

ClinO – see in particular article

  • Art. 5 Rules of GCP
  • ClinO - Clinical Trials Organisation
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • GCP – Good Clinical Practice
  • HRA – Human Research Act
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO - International Organisation for Standardisation
  • IMP/MD – Investigational Medicinal Product / Investigational Medical Device
  • SP-INV – Sponsor-Investigator
Concept ↦ Monitoring ↦ Monitoring ↦ 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): Concept ↦ Monitoring ↦ Monitoring ↦ Aim

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