What is it? Why is it important?

An important expected requirement for any study or research project is the ability to:

  • Provide confidence in its research results
  • Contribute to the advancement in health care


Information retrieved from Biological Material (BM) provide answer(s) to scientific questions. The source of retrieved and examined BM originate from:

  • Clinical studies, such as therapeutic or drug studies including health-related interventional studies (e.g. primary-, secondary endpoints)
  • Non-clinical studies (e.g. research question(s)


In order to provide confidence in data retrieved from BM requires that its “life cycle” from collection to analysis remains traceable.

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?

Ensure the “life cycle” of your BM remains traceable. This requires the introduction of standardized biobanking processes followed by its ongoing documentation.

A correct and traceable documentation of the sample workflow is especially important. Aspects to consider include the:


Processing and storage differ significantly between liquid and tissue specimens. Make yourself familiar with optimal processing methods.


Implement ongoing quality controls to ensure defined processes remain:

  • Valid and are correctly followed
  • Documentation is complete and quality relevant
  • Study staff remains trained

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


Declaration of Taipei – see in particular principle

  • 1 Ethical principles in medical research

Swiss Law

ClinO – see in particular section

  • Section 6 Storage of HrPD and BM in clinical studies

HRO – see in particular articles

  • Art. 5 Storage of HRpD and BM in research projects
  • Art. 24 General provision for further use
  • BM – Biological Material
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • HRO – Human Research Ordinance
  • HrPD – Health-related Personal Data
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
Concept ↦ Biobanking ↦ Biobanking in Studies ↦ Requirement

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 ↦ Requirement

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