Your Easy Guide to Clinical Studies

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:

• Standardized and validated methods
• A study applicable laboratory manual

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)

 

Document:

• 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)

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The Swiss Biobanking Platform (SBP) can provide you with support on this topic.