What is it? Why is it important?

Infrastructure includes both physical structures and logistics. Depending on the study, infrastructures are important aspects that must be carefully evaluated and planned.

Aspects to consider might include:

  • Facilities: patient examination rooms, office space, Phase I Unit, public transport, parking, etc.
  • Storage space: study documents and materials, biological samples, IMP/MD
  • Laboratory: handling and analysis of biological samples
  • Logistic tools: freezers, measuring instruments, computers, printers, defibrillator, etc.

What do I need to do?

Based on the planned study, define study infrastructure and storage requirements and compare against current local inventory.

Clarify and ensure access to:

  • Local infrastructure at planned study site
  • Additional premises including blocking of required time slots
  • Availability of local storage space

Whether it is an IMP/MD, study documents, or biological material, access control including protection against damage must be guaranteed.

Include required infrastructure in the cost estimate of your study.

More

The cost estimate should cover required infrastructure from concept until completion. Do not forget the archiving period that will require many years of available storage space.

Where can I get help?

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

External Links

Swissethics- – see in particular

  • Suitability and availability of infrastructure

Efbs.admin.ch – see in particular

  • Transport of biological material

References

ICH GCP E6(R2) – see in particular guidelines

  • 4.0 Site-INV qualification
  • 4.2 Adequate Resources
  • 5. SP-INV Responsibilities

ISO 14155:2020 Medical devices – see in particular sections (access liable to costs)

  • 9 Responsibilities of the sponsor (SP-INV)
  • 10 Responsibilities of the principal investigator (Site-INV)
  • 10.3 Qualification of investigation site

Swiss Law

ClinO – see in particular articles

  • Art. 18 Storage of health related data and biological material
  • Art. 45 Data retention

HRO – see in particular article

  • Art. 5 Storage of health related data and biological material
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • HRO - Human Research Ordinance
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
  • IMP/MD – Investigational Medicinal Product / Medical Device
Concept ↦ Management ↦ Resources ↦ Infrastructure
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): Concept ↦ Management ↦ Resources ↦ Infrastructure

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