What is it? Why is it important?

The quality of any information provided by the analysis of Biological Material (BM) will highly depend on its handling conditions (e.g. sample workflow). Only standardized and traceable biobanking processes can provide confidence in analytical results.


BM used for research is mainly collected based on a:

  • Specific purpose, such as from participants in a given study (e.g. the research purpose is defined in a study protocol)
  • More general purpose, such as the context regarding the further-use (e.g. the research purpose is defined after the collection of BM)


Leftover BM can also be used for further-use research purposes. It encompasses potentially leftover material not used in a study or needed for diagnostic purposes. Leftover BM originates from:

  • Study participants
  • Hospital patients following diagnostic or therapeutic procedures
  • Autopsies
  • Organ donations from living or dead humans


Irrespective of the source of acquired BM, donors of BM must agree to have their biological specimens and data used for research.

What do I need to do?

In order to have confidence in your research results, ensure you only use high quality BM for research.


Quality checks include:


Not only researchers want to ensure access to high quality BM, but also publishers of scientific journals want confidence that results were obtained from high quality samples. Only professionally managed biobanks are able to deliver the required confidence.

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

SOPs, Forms and Templates – see in particular

  • Improvement Management SOP
  • Quality policy
  • Quality Manual


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

  • 7.8 Quality control of BM and associated data
  • 8 Quality management system requirement
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • ICF – Informed Consent Form
  • MTA – Material Transfer Agreement
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
Concept ↦ Biobanking ↦ Biobanking in Studies ↦ Sample Quality

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): Concept ↦ Biobanking ↦ Biobanking in Studies ↦ Sample Quality

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