What is it? Why is it important?

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
  • Non-clinical studies addressing a research question(s) (e.g. HRO research)

 

The aim of collecting BM can serve a:

  • Specific purpose: where BM is collected from study participants and the research purpose is defined in a planned study protocol
  • General purpose: where BM is collected in the context of further-use and the research purpose is defined after the BM has been collected

 

The quality of any information provided by the analysis of BM depends on how BM was handled during the sample workflow (e.g. from collection to analysis). Only standardized and traceable biobanking processes provide confidence in analytical results.

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Leftover BM can also be used for research purposes. It includes leftover material collected in a study or for diagnostic purposes. Leftover BM originates from:

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

What do I need to do?

As a SP-INV and project leader of a HRO project, make yourself familiar with biobanking requirements applicable to your study.

 

Based on your study:

  • Know the law that apply to the handling of BM for research purposes (e.g. HRO, ClinO)
  • Assess resources needed for the set-up of your biobank
  • Define the governance and regulation of your biobank
  • Plan sample workflow processes and quality control steps needed to guarantee the quality of your BM
  • Define how donor consent (to the use of BM for research purposes) is guaranteed
  • Define how to ensure biobanking processes and requirements are documented and traceable

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

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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.

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

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

References

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
Abbreviations
  • 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
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): Concept ↦ Biobanking ↦ Biobanking in Studies ↦ Requirement

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