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 required 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

 

Upon a monitoring visit, the Site-INV is responsible to provide the monitor with all the required 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

References

ICH GCP E6(R2) – see in particular guideline

  • 5.18 Study monitoring

ISO 14155 – see in particular section

  • 8.2.4 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
  • FOPH – Federal Office of Public Health
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organization for Standardization
  • 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
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 Quality and Risk
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): Development ↦ Quality and Risk ↦ Quality Control ↦ Monitoring

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