What is it? Why is it important?

After completion of the site initiation visit (SIV), routine monitoring (RM) visits are carried out during study conduct, up until study end or end of participant recruitment.

During RM visits the monitor gains oversight of study progress to ensure:

  • Participant safety, rights, and well-being are protected
  • The quality and integrity of study data
  • The site conducts the study in compliance with the study protocol, GCP, and applicable laws and regulations

What do I need to do?

As a Monitor:

  • Perform RM visits according to the MP
  • Check site compliance and integrity of data
  • Support local study staff during on-site visits
  • Report any findings or required action items to SP-INV

As a Site-INV:

  • Have site management up-to-date (e.g. data entry, document filing)
  • Provide documents upon request
  • Answers queries and implements corrective actions

As SP-INV:

  • Review the RM visit report
  • Decide on necessary corrective measures
  • Provide ongoing support to the study site

For more information refer to Monitoring and Documents 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

  • 5.0 Quality management
Abbreviations
  • CTU – Clinical Trials Unit
  • GCP – Good Clinical Practice
  • MP – Monitoring Plan
  • RM – Routine Monitoring
  • Site-INV – Site-Investigator
  • SIV – Site Initiation Visit
  • SP-INV – Sponsor-Investigator
Conduct ↦ Quality and Risk ↦ Monitoring ↦ Routine
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): Conduct ↦ Quality and Risk ↦ Monitoring ↦ Routine

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