What is it? Why is it important?

Study monitoring requirements are:

 

Monitoring:

 

A study monitor:

  • Is in most cases the main line of communication between SP-INV and study site
  • Is independent of the study site being monitored (e.g. foremost the Site-INV),  including any study activities to be monitored
  • Reports to the SP-INV ongoing study progress, including recorded irregularities at the study site
  • Supports the study site to ensure compliance with the study protocol, GCP, and applicable laws and regulations (e.g. HRA , swissethics guidelines)

What do I need to do?

As a SP-INV define which Swiss law(s) is applicable to your study.

Monitoring activities are:

  • Mandatory for studies conducted under the ClinO and ClinO-MD
  • Possible but not mandatory for studies conducted under the HRO

 

When deciding to include a monitor in your study:

  • Make sure you employ a qualified monitor
  • Be aware that the monitor should work according to an SOP, that describes monitoring procedures, including respective staff responsibilities (e.g. how to plan, set up, and conduct study monitoring)

 

The SP-INV can delegate monitoring activities to a contractor/CRO/local CTU, but remains responsible for the quality of any delegated services. As agreed, the SP-INV or the delegated party is responsible to provide applicable monitoring SOPs.

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
  • ClinO – Clinical Trials Ordinance
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • GCP – Good Clinical Practice
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – Standard Operating Procedures
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor-Investigator
Concept ↦ Monitoring ↦ Monitoring ↦ Study Requirement
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
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
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 Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Concept ↦ Monitoring ↦ Monitoring ↦ Study Requirement

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