What is it? Why is it important?

During on-site monitoring 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:

  • Existence of study participants and proof of their agreement to participate in the study (e.g. singed ICF)
  • Participant eligibility criteria: every participant fulfils study inclusion/exclusion criteria (e.g. source data (SD) verification (SDV)) 
  • Database: Entries made in the study database (eCRF) correspond to original data in medical records (e.g. source data verification (SDV))
  • Whether the  filing of required documents is complete such as: 
    • The Master File (TMF) if the site is also the SP-INV
    • The Investigator-Site File (ISF)
  • IMP/MD handling: inventory, storage conditions, and access rights


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?

As a monitor define on-site monitoring tasks, such as whether:

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


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 ICF
  • Has the data been correctly entered into the study database (eCRF)? The monitor compares SD with entries made in the CRF of the study database
  • Is all study staff trained and delegated 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


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
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • IC – Informed Consent
  • ICH – International Council for Harmonisation Good Clinical Practice
  • IMP – Investigational Medicinal Product
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • ISF – Investigator Site File
  • ISO – International Organisation for Standardisation
  • SD – Source Data
  • SDV – Source Data Verification
  • TMF – Trial Master File
Development ↦ Monitoring ↦ Montoring Strategy ↦ On-Site Monitoring

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Monitoring ↦ Montoring Strategy ↦ On-Site Monitoring

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