What is it? Why is it important?

The monitor personally visits the site to be monitored.

During on-site visits, the monitor has access to and can check the following information or documents:

  • TMF and/or ISF: filing of required documents is complete
  • Database: according to SD entries are accurate. Thus, entries in the database correspond to original data in medical records
  • Patient files: every participant fulfils study eligibility criteria
  • IMP/MD handling: inventory, storage conditions, and access rights

More

The monitor performs the monitoring visit according to the monitoring plan, which defines extent of monitoring and tasks to be performed.

What do I need to do?

Define on-site monitoring tasks, such as whether:

  • Essential documents are filed in TMF/ISF
  • Only documents approved by EC/RA are used
  • Participants have dated and signed the IC and study procedures start only after the participant has signed it
  • Participants fulfil study inclusion and exclusion criteria based on their medical records
  • Data are correctly entered in the study database
  • IMP is stored according to specifications (e.g. temperature)

More

While monitoring, the monitor may ask the following questions:

  • Have all participants agreed to participate in the study? The monitor checks that all participants have signed the correct and approved IC
  • Has the data been correctly entered into the study database? The monitor compares SD with entries made in the CRF of the study database
  • Is all study staff trained to perform their study-specific tasks? The monitor checks staff training documents according to delegated and documented study responsibilities
  • Have patient safety issues been handled correctly? The monitor checks documentation on implemented safety reporting procedures

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

  • 4.9 Records and reports
  • 5.18 Monitoring activities

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

  • 7.5 Clinical investigation documents and documentation
  • 9.2.4 Monitoring
Abbreviations
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • IC – Informed Consent
  • IMP – Investigational Medicinal Product
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • ISF – Investigator Site File
  • SD – Source Data
  • TMF – Trial Master File
Development ↦ Monitoring ↦ Montoring Strategy ↦ On-Site
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 ↦ On-Site

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