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?

Establish a tracking tool able to document adaptations and/or changes in study activities, such as:

  • Study staff: fluctuations, introduction of novel tasks and responsibilities
  • Partners: fluctuations, new partners (e.g. study sites, service providers)
  • Study amendments: procedures based on study protocol, EC/RA approvals
  • Safety: IB updates, adaptations in IMP/MD handling and administration
  • QMS: adaptations in risk control measures, SOPs, WIs
  • Finances: change in funding providers

For more information refer to Documents in this Study Guide.

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

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

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

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

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