What is it? Why is it important?

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

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


To provide confidence in data retrieved from Biological Material (BM) requires that the “life cycle” or sample workflow remains traceable (e.g. from collection to analysis). This requires the introduction of standardized biobanking processes and the documentation of BM:

  • Collection (e.g. method(s), timing)
  • Transport and reception (e.g. means, temperature, timing)
  • Processing (e.g. centrifugation, aliquoting, sequencing)
  • Storage (e.g. means and temperature, storage duration)
  • Distribution /  shipment (e.g. means, timing, temperature)
  • Analysis (e.g. methods)


Based on the type of BM, processing and storage requirements can differ significantly.


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.


BBMRI-ERIC is a European biobanking research infrastructure dedicated to support researchers in high quality biomedical research. Across Europe, they manage a catalogue of available biospecimens and its associated data. As an infrastructure they can provide you with valuable support in accessing required biospecimens.

What do I need to do?

As a SP-INV and project leader of an HRO project, make yourself familiar with the optimal handling of BM applicable to your research.


Assess aspects that ensure the quality of your BM and its implication. Quality control aspects include:

  • To define quality indicators: are performance indicators regarding critical biobanking steps
  • To plan data monitoring: activities that check the correctness of data entered into the biobanking database
  • To include method validation: implemented tests that ensure biobanking methods and procedures are quality based and fit for purpose


During study conduct ongoing quality controls ensure:

  • Defined biobanking processes and methods remain valid and are correctly implemented
  • Responsibilities are clearly defined and remain trained
  • The handling of BM during sample workflow is documented and traceable
  • The biobanking database is correct and complete
  • Study participant and donor consent is available

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

SOP, Forms and Templates – see in particular

  • Quality control strategy SOP
  • Data Quality SOP
  • Biological Material Management SOP
  • Quality control strategy implementation SOP


  • 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

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
  • 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 ↦ Quality of Biological Material

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): Concept ↦ Biobanking ↦ Biobanking in Studies ↦ Quality of Biological Material

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