What is it? Why is it important?

A study can last for many years. Tracking is an effective tool used to monitor study progress and might include:

  • Adherence to study milestones:
    • Participant recruitment within timelines as defined by the study protocol
    • Ongoing data entry including query resolution
  • Partners: service providers and the recruitment of additional study sites
  • Amendments: changes to study protocol or design, including amended study documents (e.g. study protocol, ICF, CRF)
  • QMS: risk assessment, monitoring
  • Finances

What do I need to do?

As a SP-INV and Site-INV, establish a tracking tool able to track adaptations and/or changes in study activities including study documents, such as:

  • Study staff: fluctuations, introduction of novel tasks and responsibilities
  • Partners: fluctuations, new partners (e.g. study sites, service providers)
  • Study amendments: changes and validity of essential documents (e.g. study protocol, ICF)
  • Study approval(s): submission to the Ethics Committee (EC) and Swissmedic 
  • Safety: IB updates, adaptations in IMP/IMD handling and administration
  • QMS: adaptations in risk-control measures, SOPs, WIs
  • Finances: change in funding providers


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

  • 1.44 Protocol definition
  • 6. Clinical trial protocol and protocol amendment(s)
  • 7. Investigators brochure

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

  • 6.4 Clinical investigation plan
  • 6.5 Investigators brochure
  • 7.5.1 Amendments
  • CTU – Clinical Trials Unit
  • CRF – Case Report Form
  • EC – Ethics Committee
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • CRF – Case Report Form
  • IB – Investigator’s Brochure
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISO – International Organization for Standardization
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor Investigator
  • QMS – Quality Management System
  • WI – Working Instructions
Development ↦ Management ↦ Study Management ↦ Tracking

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 ↦ Management ↦ Study Management ↦ Tracking

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