What is it? Why is it important?

Infrastructure includes both physical structures and logistics. Depending on the study, infrastructures are important contributing factors to the successful implementation of a study and must be carefully evaluated and planned.


Aspects to consider might include:

  • Facilities: patient examination rooms, office space, storage and archiving facilities, a phase I unit, pharmacy, access to public transport, parking space, suitable facilities for disabled study participants etc.
  • Storage means: access protected storage means for study documentsbiological material (e.g. freezers), IMP/IMD, additional study material
  • Laboratory: handling and analysis of biological material (e.g. centrifuge, analytical tools)
  • Logistic tools: computers, printers, IT support, safety equipment such as defibrillator, transport logistics (e.g. communication, study material, biological material)

What do I need to do?

As a SP-INV or Site-INV, define study infrastructure requirements and compare against current local inventory. Implement an infrastructure feasibility assessment.


Clarify and ensure access to:

  • Logistics equipment and support needed for study conduct
  • Additional premises including blocking of required time slots (e.g. patient examination facilities)
  • Adequate local storage facilities that are access protected and if needed temperature controlled
  • Local infrastructure at planned participating study site (e.g. multi-centre study)


Irrespective of whether it concerns study IMP/MD, study documents/materials, or biological material, ensure ongoing access control, and protection against loss or destruction.


Include required infrastructure in the cost estimate of your study. The budget 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

Swiss Exp.Com.Biosafety – see in particular

  • Transport of biological material


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
  • 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
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
Concept ↦ Management ↦ Resources ↦ Infrastructure

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
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 Protocol
Conduct Statistics
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Concept ↦ Management ↦ Resources ↦ Infrastructure

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