What is it? Why is it important?

The aim of a biobank governance is to ensure that the management of the biobank is running based on:

  • Applicable laws (e.g. HRA), ethics requirements (e.g. EC, Decl. of Taipei) and biobanking guidelines (e.g. ISO)
  • Harmonised processes
  • Allocation of responsibilities
  • Required resources, infrastructure and equipment
  • Re-traceable and access protected documentation
  • Law compliant database including qualified IT support
  • Correct handling of Biological Material (BM)
  • A risk-based QMS including the planning of risk control-measures
  • Defined contact points
  • An organigram including reporting timelines
  • Required education and ongoing training of biobanking staff
  • Subject rights and Informed Consent from all subjects donating BM for research

What do I need to do?

You can contact the SBP-platform. They can assist you with many of the requirements addressed in ISO and the Declaration of Taipei. They can provide you with support including documents needed for the set-up and competent running of a Biobank.

Where can I get help?

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

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

SBP Documents


  • Biobank Regulation


External Links

Swissethics – see in particular

  • Topics / Biobanks and data registries


Declaration of Taipei – see particular principle

  • Health database and biobank governance

ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) – see in particular

  • 8 Quality management system requirement

Swiss Law

HRA - See in particular

  • Art. 43 Storage

HRO – see in particular article

  • Art. 5 Storage if biological material
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ISO – International Standards Organisation
  • IT – Information technology
  • QMS – Quality Management System
  • SBP – Swiss Biobanking Platform
Concept ↦ Biobanking ↦ Management of a Biobank ↦ Biobank Goverance

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 ↦ Biobanking ↦ Management of a Biobank ↦ Biobank Goverance

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