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) (human and non-human origin) and associated data. Its organised framework ensures the quality of BM and its associated data used in research, including diagnostic and therapeutic purposes.


BB activities include the regulation and harmonisation of processes used for the handling of BM. This includes the entire life-cycle of a given biological sample, referred to as the "sample workflow", and includes sample:


What do I need to do?

As a SP-INV, make yourself familiar with the field of biobanking, such as:

  • Infrastructure and technical equipment (e.g. access-controlled storage rooms, freezers, 24-hour temperature monitoring)
  • Resources for managing a BB (e.g. BB staff, infrastructure, finances)
  • Software to document and track BM (e.g. BIMS)
  • Processes to ensure the ongoing quality of BM during the entire sample workflow
  • Training of personnel responsible for BB activities
  • Restricted access and adherence to data protection laws
  • BB-governance and SOPs that define 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.

SBP Documents

Ethic & Legal

  • Ethical, legal and professional compliance list for human research biobanks applicable in Switzerland

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 of biobanking

Swiss Law

ClinO – see in particular article

  • Art. 18 Storage of health-related personal data and biological material

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 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): Basic ↦ Biobanking ↦ Definition ↦ Biobank

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