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/MD, and applicable laws

The study SP-INV is responsible to appoint a qualified study monitor. The SP-INV can delegate monitoring tasks to a CRO or to one of the public CTUs 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

References

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 – search for “good practice”

ClinO – see in particular article

  • Art. 5 Rules of GCP
Abbreviations
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • GCP – Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • SP-INV – Sponsor-Investigator
Concept ↦ Monitoring ↦ Monitoring ↦ 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): Concept ↦ Monitoring ↦ Monitoring ↦ Aim

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