What is it? Why is it important?

A biobank (BB) is an organized entity with a governance in place, responsible for the management of Biological Material (BM). It provides an organised framework required to ensure the quality of BM used in research as well as for diagnostic and therapeutic purposes.


BB activities include the regulation and harmonisation of processes used for the handling of BM, such as biological sample:


Biological samples are BMs of human and non-human origin

What do I need to do?

As a SP-INV, make yourself familiar with requirements needed for the management and set-up a BB, such as:

  • Required infrastructure and technical equipment (e.g. access controlled storage rooms, freezers, 24 hour temperature monitoring)
  • Required resources needed for BB management
  • Software needed for the documentation and tracking of BM (e.g. BIMS)
  • Processes to ensure the ongoing quality of stored BM (e.g. correct handling, processing, storage conditions)
  • Training of BB responsible study personnel
  • Restricted access and adherence to data protection laws
  • A BB governance document that defines BB management and responsibilities

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.

External Links

Swissethics – see in particular

  • Topics / Biobanks and data registries


Declaration of Taipei – see in particular

  • Health database and biobank governance

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

  • 3.6 definition biobanking

Swiss Law

HRO – see in particular article

  • Art. 5 Storage of biological material
  • BB – Biobank
  • BIMS – Biobank Information Management System
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • HRO – Human Research Ordinance
  • ISO – International Standards Organisation
  • SBP – Swiss Biobanking Platform
  • SP-INV – Sponsor Investigator
Basic ↦ Biobanking ↦ Definition ↦ Biobank

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): Basic ↦ Biobanking ↦ Definition ↦ Biobank

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