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).


In studies, biobanks are responsible for the workflow management of BM (e.g. collection, transport, processing, storage, analysis, and if applicable destruction)


Biobank management include aspects such as:


Upon collection, biological samples should be coded as quickly as possible. This ensures that participant identity remains concealed (data confidentiality), and data protection issues are respected at all times.

What do I need to do?

As a SP-INV and Site-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


In order to ensure reproducibility and comparability of analytical results, the handling of BM must remain consistent. Thus, define standardised:

  • Collection and transport procedures (e.g. collection tubes, approved stabilisers, transport on dry ice)
  • Sample processing and storage conditions
  • Analytical procedures


Define maximum acceptable time-lapse between different handing steps. Delays may jeopardize the quality of BM. Ensure all implemented handling steps are well documented.


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

SECB - see in particular Topics / Definitions

  • Transport of biological material


Declaration of Taipei – see in particular

  • Health database and biobank governance

ISO 20387:2018 General requirement for biobanking (access liable to costs) – see in particular

  • 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 health-related personal data and biological material
  • BB – Biobank
  • BIMS – Biobank Information Management System
  • BM – Biological Material
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • HRO – Human Research Ordinance
  • ID – Identity
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • SBP – Swiss Biobanking Platform
  • SECB – Swiss Expert Committee for Biosafety
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor Investigator
Development ↦ Management ↦ Biobanking ↦ Management

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): Development ↦ Management ↦ Biobanking ↦ Management

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