What is it? Why is it important?

Biobanking operations during study / research project conduct requires the ongoing compliance with its processes, defined during the development and set-up phase. The aim is to guarantee:


Compliance includes:


In addition, ongoing compliance with international guidelines, EC, Declaration of Helsinki and Taipei, quality standards (e.g. ISO), ICH-GCP, and regulatory requirements are expected (e.g. Swiss law).


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?

Based on the successful set-up of your biobank. Ensure to retain control over:

  • Donor consent and withdrawal processes
  • Data protection, traceability, and data integrity (e.g. data monitoring from collection until analysis or destruction)
  • Maintenance of biobanking facilities (e.g. laboratory equipment, consumables, freezers)
  • Biobanking risk surveillance to evaluate whether:
    • Identified risks are well controlled or if new control-measures are required (e.g. implemented safety procedures, emergency plans)
    • New risks are identified (e.g. related to new activities or new equipment)
  • Quality control (QC) and the compliance with defined QC-Indicators (e.g. sample-workflow processes)
  • Non-conformities and the implementation of improvement measures
  • Ongoing training of biobanking staff, including potential study collaborators
  • Documentation of the above steps in BIMS and / or in other sources


Compliance with Biobanking Operations can be assessed during biobank audits.


During study conduct make sure to monitor biobanking processing on an ongoing basis. Here some monitoring examples:

  • At collection site are donor safety and rights guaranteed?
  • Upon collection, are biological specimens always kept and transported on dry ice to the laboratory?
  • Is the laboratory always informed ahead of time regarding donor visits and the prospect of incoming samples?
  • Is everyone aware of required time constraints under which biological specimens  must be frozen or fixated
  • Are all steps, including non-conformities, documented in BIMS or other relevant study documents?
  • In order to guarantee data integrity, are guidelines complied with from collection until analysis or destruction of BM (e.g. data audit trail, ALCOA principles)
  • Are donor consent withdrawal processes correctly implemented, and can a donor withdraw from the study without having to provide any justification?
  • In the event of donor withdrawal, have donor samples been destroyed upon analysis, or have they been anonymized? (e.g. given donor did not dissent to anonymization)

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

  • Biological Material Management SOP
  • Sample tracking form
  • Risk Management SOP

External Links

Swissethics – see in particular

  • Topics/Biobanks and data registries


ICH GCP E6(R2) – see in particular guideline

  • 5.18.3 Extent of Monitoring

Declaration of Helsinki – Ethical principles for medical research involving human subjects

Declaration of Taipei – provides ethical principles on the handling of biological material

BBMRI-ERIC – is a European research infrastructure for biobanking. The aim is to bring together all the main players from the biobanking field – researchers, biobankers, industry, and patients – to boost biomedical research

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

Swiss Law

HRA – Federal act on research involving human beings

  • ALCOA – Attributable, Legible, Contemporaneous, Original, Accurate
  • BIMS – Biobanking Information Management System
  • BM- Biological Material
  • BBMRI-ERIC – Biobanking and Biomolecular Resources Research – European Research Infrastructure Consortium
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRA – Human Research Act
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Standards Organization
  • QC – Quality Control
  • SBP – Swiss Biobanking Platform
  • SOP- Standard Operating Procedure
Conduct ↦ Biobanking ↦ Biobanking Operation ↦ Processes

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 Statistic Methodology
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 Statistic Methodology
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 Statistic Methodology
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Biobanking ↦ Biobanking Operation ↦ Processes

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