Your Easy Guide to Clinical Studies

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)

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)

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