What is it? Why is it important?

Biobank owners responsible for the set-up and management of biobanks can apply for SBP Quality Labels (SBP Labels). Labels confirm the quality of biobanking processes and as a result the quality of its Biological Material (BM).

 

SBP Labels are awarded based on proven compliance with a given set of criteria. SBP Labels include a:

  • VITA Label: confirms compliance with ethics and legal requirements
  • NORMA Label: confirms compliance with standardized operational biobanking processes
  • OPTIMA Label: confirms compliance with defined quality management standards and the implementation of quality assurance measures

 

The SBP Labels align with international ISO standards on Biobanking (ISO 20387).

What do I need to do?

To apply for a SBP Label:

  • Register your biobank in the Biobank SQAN online tool
  • Fill in the online questionnaire to reflect the operational processes of your biobank (e.g. 250 questions addressing biobanking governance, resources, processes, and quality assurance)

 

The SBP evaluates:

  • Information provided from the online questionnaire
  • Potentially requested biobanking documents
  • Information gathered during biobanking on-site visit(s) (e.g. only required for NORMA and OPTIMA QL)

 

During quality evaluations the SBP also provides active support to researchers (e.g. documents needed to cover for identified gaps).

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 - see in particular

  • SBP Labels: Quality with biobanking best practice standards
  • SBP-SQAN – Biobank for Solution Quality assessment and normalization

SBP Documents

General

  • Quality Manual

SOPs, Forms and Templates – see in particular

  • Improvement Management SOP
Abbreviations
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • ISO – International Organization for Standardization
  • QL – Quality Labels
  • SBP-QL – Swiss Biobanking Platform Quality Labels
  • SBP-SQAN – Swiss Biobanking Platform Biobank Solution for Quality Assessment and Normalization
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
Basic ↦ Biobanking ↦ Swiss Biobanking Platform ↦ Quality Labels
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Set-Up

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
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

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): Basic ↦ Biobanking ↦ Swiss Biobanking Platform ↦ Quality Labels

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