What is it? Why is it important?

Monitoring oversees the progress of a study in order to ensure that:

The extent of monitoring is adapted according to study risk(s) and type of study under the law (e.g. ClinO versus HRO).


The SP-INV is responsible for the monitoring of the study, which can be delegated to the CTU or a CRO. Any delegation must be documented in a contract.

What do I need to do?

As a SP-INV:

  • Select the type of monitoring required for your study (e.g. centralised, on-site, or a combination of both)
  • Prepare a Monitoring Plan (MP), which documents the monitoring strategy for your study (e.g. extent and nature of monitoring)
  • Appoint a monitor who
    • Has relevant scientific knowledge and experience
    • Is independent of the study
  • In the event study monitoring services are outsourced, ensure to document its strategy, responsibilities, and costs in a contract


During a monitoring visit, the Site-INV is responsible to provide the monitor with all requested documents (e.g. quality documents) needed to perform the required Quality Control activities.


For more information refer to Monitoring in this Study Guide

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 Study monitoring

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

  • 8.2.4 Monitoring

Swiss Law

HRA – search for “good practice”

ClinO – see in particular article

  • Art. 5 Rules of GCP
  • ClinO – Clinical Trials Ordinance
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organization for Standardization
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • MP – Monitoring Plan
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
Development ↦ Quality and Risk ↦ Quality Control ↦ 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 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 Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Quality and Risk ↦ Quality Control ↦ Monitoring

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