What is it? Why is it important?

Many procedures are implemented between the collection of Biological Material (BM) and its analysis (e.g. sample workflow). In order to make biobank procedures reproducible requires that validated methods are used.


A validated method is a method that has provided evidence that its procedures are proven to be fit for purpose in terms of quality, reliability and consistency.


The introduction of new or modified methods require that they are initially tested regarding:

  • Fit for purpose (e.g. a method is able to do the job, or reach the originally defined aim)
  • Ability to yield identical results every time procedures are repeated (e.g. DNA extractions provide identical DNA purities and quantities, identical cryopreservation procedures result in comparable amounts of viable cells)

What do I need to do?

Make a list of methods used for the handling of BM. Whenever possible, implement internationally validated methods.

The use of validated methods greatly facilitate the comparison between BM samples, and provide confidence in the reliability and consistency of analytical results.


In the event a validated method does not exist for a planned procedure (e.g. new method to isolate PBMC, new type of reagent to extract DNA, new type of centrifuge to pellet cells), set-up a validation protocol that includes the following steps:

  • A description of the expected method aims. What results are expected and what is the acceptance range (e.g. number of isolated viable cells, % of DNA purity)
  • A test phase that assesses the performance of the method by repeating the method several times (e.g. method robustness and predictability)
  • Based on the above points, a decision whether the method can be approved or must be rejected. An approved method is considered as validated (e.g. results are within the expected acceptance range)
  • A detailed documentation of performed validation steps including results (e.g. in a validation protocol)

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

  • Validation of Methods SOP
  • Method List
  • Method validation record
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • DNA – Deoxyribonucleic acid
  • PBMC – Peripheral Blood Mononuclear Cells
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedure
Development ↦ Biobanking ↦ Quality Control ↦ Method Validation

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 ↦ Quality Control ↦ Method Validation

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