Site monitoring in Scandinavia: Language Requirements
According to Good Clinical Practice (GCP) guidelines the core purpose of site monitoring is to protect study participants' rights, safety, and well-being, while ensuring the reliability of study results. A critical component of this process is the site monitor's ability to communicate with site staff, review medical records for safety events, and verify informed consent compliance. The site monitor must be independent of the site.
While Sweden, Norway, and Denmark share cultural, linguistic, and regulatory similarities, Sponsors must understand the nuances in national language expectations. Assigning site monitors who lack local language skills can lead to study approval delays, regulatory non-compliance, and audit or inspection findings.
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