What is it? Why is it important?

Study monitoring requirements are:

  • Defined by the study SP-INV
  • Outlined in a monitoring plan

Monitoring:

  • Is performed by a site independent monitor on behalf of the SP-INV
  • Findings are documented in a monitoring report to be reviewed and approved by the SP-INV of the study
  • Findings are assessed and improvement measures are implemented

More

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 including any study activities to be monitored
  • Reports ongoing study progress, including recorded irregularities at the study site, to the SP-INV
  • 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?

Define which Swiss law is applicable to your study.

Monitoring activities are:

  • Mandatory for studies conducted under the ClinO
  • Allowed but not required for studies conducted under the HRO

When deciding to include a monitor in your study:

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

More

The SP-INV can delegate monitoring activities to a private CRO or to one of the public CTUs. In that case, it is the responsibility of the delegated party to provide applicable monitoring SOPs, including the monitoring plan of the study.

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 – Contact Research Organisation
  • CTU – Clinical Trials Unit
  • GCP – Good Clinical Practice
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • 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
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 ↦ Study Requirement

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