What is it? Why is it important?

Routine Monitoring (RM) is carried out once participant recruitment has started until study closure or end of participant recruitment.

During RM the monitor gains oversight of study progress and site compliance to ensure that:

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

Findings or inconsistencies are documented in a monitoring report.

More

Study monitoring activities are followed based on specifications described in the monitoring plan (MP). The MP is defined by the SP-INV and adapted based on:

  • Expected study risks: Risks are evaluated using a risk-based approach towards study monitoring
  • Type of monitoring: On-site monitoring, centralized monitoring, including a combination of both monitoring types
  • Documented findings during study conduct. An increase in study findings and inconsistencies may result in an increase in monitoring activities (e.g. increase numbers of RM visits, increase of the extent of data monitoring). An unexpected increase in monitoring activities might increase the study budget

What do I need to do?

The Site-INV:

  • Provides the monitor with all required documents necessary to evaluate compliance (e.g. source documents, CRFs/access to study database, filing of study documents in the ISF)
  • Discusses findings with the monitor in order to find appropriate solutions. Outstanding issues from previous RM visits should be included.
  • Implements corrective measures and ensures applicable staff is trained on improvement measures, applicable new processes or changes
  • Outstanding issues which cannot be closed during the visit should be solved as soon as possible after the monitoring visit

For more information refer to Monitoring and Quality and Risk 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 guidelines

  • 5.18. Monitoring
  • 4.5. Protocol compliance
  • 4.11 Safety reporting
  • 6.10 Monitoring access to source data

ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)

  • 6.7 Monitoring Plan
  • 7.3 Investigational site monitoring
  • 9.2.4 Monitoring

Swiss Law

ClinO – see in particular article

  • Art. 5. Rules of good clinical practice
Abbreviations
  • CRF – Care Report Form
  • CTU – Clinical Trials Unit
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • MP – Monitoring Plan
  • RM – Routine Monitoring
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Conduct ↦ Management ↦ Responsibility and Oversight ↦ Routine 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 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 ↦ Management ↦ Responsibility and Oversight ↦ Routine Monitoring

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