What is it? Why is it important?

In studies, different storage requirements become necessary.

Main requirements include storage of:

  • IMP/MD
  • Biological samples
  • Required study documents
  • Additional material neded during study implementation
  • Archived study documents/meterial upon study completion

Storage facilities must guarantee:

  • Access control with restricted admission only provided to applicable study staff
  • Audit trail tracking 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?

Based on your study, define storage requirements and its management.

Evaluate and clarify:

  • How access to appropriate storage facilities can be restricted and controlled and how access can be 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

Efbs.admin.ch – see in particular

  • Transport of biological material

Swissethics – see in particular

  • Suitability and availability of infrastructure

References

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
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
  • IMP/MD – Investigational Medicinal Product / Medical Device
Concept ↦ Management ↦ Resources ↦ Storage
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 ↦ Storage

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