ISO 14155 - Electronic clinical data systems - Definition

Wolf.K

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#1
Hi,

I wonder if someone has an idea about the definition of ISO 14155' "electronic clinical data systems", chapter 6.8.3:

If I get print-outs of (anonymized) patient records and do some statistical calculation with the data for either a scientific publication or for the clinical evaluation of a device - is this data processing already what ISO 14155 calls an "electronic clinical data system"??

:confused: Wolf
 
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