What is it? Why is it important?

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


This might include:

  • Facilities: patient examination room / office space / Phase I Unit / parking
  • Storage: study material / biological material / IMP/IMD including temperature and access control
  • Laboratory: handling and analysis of biological material (e.g. sample workflow)
  • Logistic tools: transportation systems, freezers, measuring instruments, computers, printers, defibrillator
  • Communication network: methods used to facilitate communication within a team, and with partners


Inventory management:

What do I need to do?

As a SP-INV and Site-INV, define for your study:

  • The study 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/IMD 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/IMD, study material)


Stored study material (e.g. IMP/IMD, biological material, archived study 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/IMD 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 (e.g. logs) 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
  • CTU – Clinical Trials Unit
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • SOP – Standard Operating Procedures
  • WI – Working Instructions
Development ↦ Management ↦ Study Management ↦ Infratructure and Maintenance

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 ↦ Infratructure and Maintenance

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