What is it? Why is it important?

Infrastructures include both physical structures and logistics required for the successful implementation of a study.

This might include:

  • Facilities: patient examination room / office space / Phase I Unit / parking, etc.
  • Storage: study material / biological material / IMP/MD including temperature and access control
  • Laboratory: handling and analysis of biological material
  • Logistic tools: freezers, measuring instruments, computers, printers, defibrillator, etc.

Inventory management:

What do I need to do?

For your study, define:

  • Required infrastructure
  • Maintenance requirements in order to guarantee faultless functioning of study equipment (e.g. freezers, analytical equipment, computers)

Provide or write relevant:

  • SOPs or WIs for handling of study equipment (e.g. IMP/MD storage, utilisation of analytical or other study material, processing of biological material)
  • Documents for inventory / traceability checks from arrival, retrieval until destruction (e.g. IMP/MD, study material)

For more information refer to Biobanking and Drug or Device in this Study Guide.

More

Stored study material (e.g. IMP/MD, biological material, archived documents) must be monitored on an ongoing basis to ensure proper storage conditions. Processes and emergency procedures should be in place.

Example Freezer break-down

  • Is there a reserve freezer in place?
  • What redistribution procedures must be followed?
  • How is the beak-down event and any material redistribution documented?
  • How is study staff informed?

Example IMP/MD handling

  • Are there inventory / traceability logs in place?
  • How is access control monitored?
  • How is temperature monitored during transport, stock transfer, and shipment?
  • How is temperature monitored during storage?

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissethics – in particular see

  • Suitability and availability of infrastructure
Abbreviations
  • CTU – Clinical Trials Unit
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product / Medical Device
  • SOP – Standard Operating Procedures
  • WI – Working Instructions
Development ↦ Management ↦ Study Management ↦ Infratructure and Maintenance
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 ↦ Infratructure and Maintenance

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