What is it? Why is it important?

A risk-based approach is a decision-making process that takes into consideration ways to identify, evaluate, prioritise, and control risks associated with some undertaking, such as a biobank.


Potential safety-risks related to the management of a biobank can include:

  • The governance of the Biobank (e.g. biobanking processes, responsibilities, staff resources and training, applicable laws and guidelines)
  • The management of biobanking facilities and materials (e.g. work/storage space, biobanking equipment such as freezers, pipettes, labs, consumables)
  • Staff and donor safety
  • The agreement and documentation of donor consent
  • Handling of Biological Material (BM) (e.g. sample workflow)


Once risks are identified and assessed, applicable risk control-measures are implemented and checked for ongoing efficacy and applicability (e.g. risk review)

What do I need to do?

Familiarise yourself with how to identify and assess potential biobanking risks. Based on risk identification:

  • Evaluate:
    • The likelihood of risk occurrence (probability)
    • Expected impact of risk (severity) (e.g. decrease quality of BM, donor right, faulty analytical results)
  • Define risk control-measures
  • Communicate and train staff on risk management
  • Perform risk-reviews in order to check the ongoing efficacy and applicability of risk control-measures, including the potential occurrence of new risks (e.g. new equipment, new staff, new procedures)
  • Document your risk management strategy in a Risk Assessment Form


Regarding safety breaches:

  • Ensure they are immediately notified, communicated, and documented (e.g. RAF)
  • Perform a root cause-analysis and define control-measures to prevent its re-occurrence
  • Train staff


During the ongoing management of your biobank include the documentation and handling of non-conformities (NC) in your risk-based approach.

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

  • Risk management SOP
  • Annex

External Links

Swissethics – see in particular

  • Topics / Biobanks and data registries


ICH GCP E6(R2) – see in particular guideline

  • 5.0 for quality management

ISO 31000 Risk Management (access liable to costs) – see in particular section

  • Risk management: Principles and guidelines

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

  • 8.5 Actions to address risks and opportunities

Swiss Law

HRA – see in particular article and chapter

  • Art. 12 Risks and burdens
  • Chapter 3 Requirements for research involving vulnerable persons


  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • HRA – Human Research Act
  • ISO – International Organization for Standardization
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • NC – Non-Conformities
  • RAF – Risk Assessment Form
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
Development ↦ Biobanking ↦ Safety ↦ Risk-Based Approach

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): Development ↦ Biobanking ↦ Safety ↦ Risk-Based Approach

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