What is it? Why is it important?

During study conduct, the study monitor checks among others the quality and integrity of the study data.


With respect to Data Managment (DM) responsibilities, the monitor:

  • Checks whether data entry is correct and recorded in a timely manner
    • Recorded entries in the database correspond to SD (original data)
    • Data entries are done in close proximity to participant visits
  • Writes queries in the event of data inconsistencies or errors
  • Supervises query resolution by study site  (e.g. upload of query questions, query handling by study site, query resolution or pending issues)
  • Reports any inconsistencies to the SP-INV in order to define applicable corrective actions
  • Checks upon subsequent monitoring visits the implementation of any outstanding corrective actions

What do I need to do?

As a SP-INV and based on the complexity of your study (e.g. study design) and expected study risks:

  • Assess the monitoring requirements of your study and how it affects DM aspects
  • Establish a requirement profile for a study monitor


Monitoring  requirements are based on study type (ClinO, ClinO-MD, HRO) and risk category (A low risk, B or C high risk). As a SP-INV define the:

  • Frequency and type of monitoring (e.g. one or several spaced monitoring visits, on-site or central monitoring)
  • Extent of monitoring (e.g. what data to check) and the scope of data to monitor (e.g. all collected data, only a given percentage of data)


For more information refer to Monitoring in this Study Guide.


Planned study monitoring activities are summarised in the Monitoring Plan (MP) of the study. It describes the monitoring strategy by defining scope, frequency and type of monitoring. The MP must be submitted for approval to the EC prior to study start. This includes any subsequent changes or adaptations thereof.

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

  • Art. 1.38 Monitoring
  • Art. 5.5 Trial Management, data handling, and record-keeping
  • Art. 5.18 Monitoring activities

Swiss Law

ClinO – see in particular article

  • Art. 5 Rules of Good Clinical Practice.


  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • DM – Data Management
  • EC – Ethics Committee
  • HRO – Human Research Ordinance
  • MP – Monitoring Plan
  • SD – Source Data
  • SP-INV – Sponsor-Investigator
Concept ↦ Data Handling ↦ Stakeholders ↦ Monitor

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): Concept ↦ Data Handling ↦ Stakeholders ↦ Monitor

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