Tripartite clinical trial agreements in Bosnia

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As of February 2011, the clinical trials in Bosnia and Herzegovina are regulated with a tripartite agreement.

The agreement is bilingual, i.e. it is in English and in Bosnian (or Croatian and Serbian), and it needs to be certified by a sworn court interpreter.

The agreement is signed between the Institution (site), the PI, and the Sponsor.

The template of the agreement is a part of the EC regulatory approval package which needs to be submitted to the Ethics Committee 7 days before the EC session, the latest.