Anyone involved with clinical investigation should have a copy of the ISO 14155:2020 standard because it contains everything that is needed on good clinical practice, GCP. But it can be expensive if you buy it in the wrong place.

In this article, you will learn where to buy the standard for a fraction of the price compared to major outlets.

The official ISO website offers PDF, EPUB, redlined, and paper format, and combinations of those for the following prices:

 

Format Language Price
PDF+EPUB
English / French
CHF 198 (EUR ~189)
PDF+EPUB+REDLINE
English / French
CHF 238 (EUR ~227)
PAPER
English / French
CHF 198 (EUR ~189)

There are also other places where you can get access to the ISO 14155:2020, such as:

The good news is that there is a more affordable option and that is buying a copy from the Estonian Centre for standardisation and accreditation. The price there is much lower than on the official ISO website or elsewhere. And the standard is still in English.

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
PDF
EUR 26.58
PDF+REDLINE
EUR 31.90
PAPER
EUR 26.58
Another great thing about the Estonian Centre for Standardization is that they offer a variety of standards which you can “rent” for only 2€ for a day. In other words, you will have access to a standard for 24 hours during which you can browse and see if that standard is the right fit for you.
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