What is it? Why is it important?

In studies, different storage requirements become necessary.

Main requirements include storage of:

Storage facilities must guarantee:

  • Access control with restricted admission only provided to applicable study staff
  • Audit trail tracking ongoing storage and retrieval (e.g. inventory control)
  • Stable environmental conditions such as temperature and humidity control
  • Protection against fire, and rodent infestation

Facilities should be monitored on an ongoing basis to ensure that above requirements are met.

What do I need to do?

As a SP-INV and Site-INV, define the storage requirements of your study including its ongoing management.

Evaluate and clarify:

  • How access to storage facilities can be restricted and documented
  • How temperature and humidity are monitored and documented
  • How emergency procedures are implemented in the event of failure (e.g. freezer breakdown)
  • How to guarantee inventory oversight
  • How to select potential qualified storage partners (e.g. biobanking)

Ensure staff is trained regarding procedures on storage requirement including handling of emergency events.

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 Site-INV qualification
  • 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)

Swiss Law

ClinO – see in particular articles

  • Art. 18. Storage of Health data and biological material
  • Art. 45. Data Retention

HRO – see in particular article

  • Art. 5. Storage of health 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
  • IMP/MD – Investigational Medicinal Product / Medical Device
  • ISO – International Organization for Standardization
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Concept ↦ Management ↦ Resources ↦ Storage

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): Concept ↦ Management ↦ Resources ↦ Storage

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