What is it? Why is it important?

The Monitoring Plan (MP) describes the monitoring strategy of a study by defining the scope, frequency, and type of monitoring.

Important aspects to consider when defining the study MP are:

  • Study complexity (e.g. randomized-, blinded-, or cross-over designs)
  • The robustness of the study endpoint (e.g. an improvement in blood value versus scores in a self-assessment questionnaire)
  • Expected treatment risks (e.g. use of a novel drug, participation of vulnerable participants)
  • Target group (e.g. adults, children, participants without capacity)
  • The number of planned study participants

More

Regardless of whether monitoring is on-site or centralised; the MP gives the monitor guidance on relevant study monitoring tasks.

Prior to implementation, the MP of a study must be submitted to the EC for approval.

A SP-INV can delegate monitoring tasks to properly trained staff. It is important that the appointed monitor is independent of the study site being monitored. Monitoring can also be delegated to a CRO or to one of the public CTUs. Nonetheless, the SP-INV remains responsible for all monitoring

The SP-INV defines in the MP:

  • Visit type: on-site and/or centralised
  • Visit frequency: based on study risks, site performance, and study duration
  • Extent of monitoring: includes which aspects to check and to what extent (e.g. percentage of data in the database, relevant study documents, procedures such as processing of biological samples, IMP/MD storage, preparation of study drug)

What do I need to do?

Write a MP that takes into consideration the circumstances and nature of your study.

  • Use a systematic, prioritised, and risk-based approach.
  • Include some flexibility regarding the extent and nature of monitoring. An increase in the monitoring scope and/or number of visits at a study site might be triggered due to:
    • Safety concerns
    • A low recruitment rate and/or poor compliance with the study protocol
    • Major fluctuations in study staff

More

In the MP include information on:

  • Monitoring frequency. Plan more visits for high-risk studies
  • The extent of data and documents to be monitored, such as whether to check:
    • SD for 20, 40, or 100% of participants
    • All AEs or only SAEs
    • ICFs of all participants or only those chosen for SD verification
  • The extent of on-site and centralised monitoring
  • Criteria that would trigger monitoring adaptations potentially resulting in additional on-site monitoring visit(s) (e.g. irregularities found during monitoring, such as a site with a low number of reported AEs per participant as compared to other sites)
  • Potential site adaptations that might become necessary in multicentre studies

Monitoring activities consume time and resource. Remember to include applicable adaptations in your budget.

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

  • 4.5 Protocol compliance
  • 5.0 Quality management
  • 5.18 Monitoring activities
  • 6.10 Access to source data / documents

ISO 14155 Medical Device – see in particular section (access liable to costs)

  • 6.2 Risk management
  • 6.7 Monitoring plan
  • 7.8 Document and data control
  • 9.2.4 Monitoring

Swiss Law

ClinO – see in particular article

  • Art. 19 - 20 Study categorisation
  • Art. 37 – 43 Safety Reporting

HRO – see in particular article

  • Art. 7 Research categorisation
  • Art. 20 – 21 Safety Notification

Documents

Abbreviations
  • AE – Adverse Event
  • CRO – Contact Research Organisation
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • IC – Informed Consent
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • MP – Monitoring Plan
  • SAE – Serious Adverse Event
  • SD – Source Data
  • SP-INV – Sponsor-Investigator
Development ↦ Monitoring ↦ Montoring Strategy ↦ Monitoring Plan
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): Development ↦ Monitoring ↦ Montoring Strategy ↦ Monitoring Plan

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