What is it? Why is it important?

Sample analysis is the sample-workflow step where Biological Material (BM) is retrieved from short- or long-term sample storage and destined for analysis.


Processes include:

  • A quality check reviewing:
    • Documentation of BM integrity (e.g. no or few non-conformities during sample workflow)
    • Storage duration (e.g. maximum storage duration has not been exceeded) 
  • Request for BM retrieval from the biobank
  • BM retrieval and transport to the analysis site
  • Prior to analysis, potential quality controls (e.g. cell viability, adequate cell count, stable RNA)
  • Documentation of BM handling prior to analysis (e.g. intermediate storage on ice, defrosting at room temperature, sterile environment)
  • Analysis procedures and the occurrence of non-conformities
  • Lessons learned (e.g. suggestions regarding sample-workflow steps improvement)


Analysis of BM can either be based on:

What do I need to do?

Define procedures for sample analysis. Prior to analysis review deviations in:

  • Sample-workflow steps potentially affecting sample quality (e.g. sample handling between sample collection and analysis)
  • Sample storage conditions and duration (e.g. no sup-optimal temperature fluctuations, maximal storage duration were not exceeded)


Define procedures for the further-use of leftover BM not needed for the analysis (e.g. return to biobank, destruction)



  • Sample retrieval from biobank storage (e.g. date, time, transport means and temperature)
  • Intermediate storage prior to analysis (e.g. room temperature, on ice, -20°C)
  • The analysis and quality deviations (e.g. analysis date and time, non-compliance with analytical methods)
  • Qualified staff responsible for BM retrieval from storage and analysis

In the event BM do not meet acceptance criteria for analysis, include a process on how to manage these events (e.g. sample destruction, documentation or report of non-conformities)


Document procedures for a planned analysis in a SOP and/or WI describing how to request BM retrieval from storage, transport to analysis site, including the planned analysis.

Lesson learned

In the event of unexpected or incorrect results, check potential interferences with sample-workflow steps (e.g. from collection until analysis). Ask yourself what conditions might have influenced the quality of BM. By the ongoing improvement of sample-workflow steps, the provision of high quality BM and credible research results can be guaranteed.

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.

  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • SBP – Swiss Biobanking Platform
Development ↦ Biobanking ↦ Handling of Biological Material ↦ Sample Analysis

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 ↦ Handling of Biological Material ↦ Sample Analysis

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