Bilingual clinical trial agreements are standard in many non-English speaking countries. Translation from English into local language can be either performed by the negotiator, or this can be outsourced to a certified vendor. In this article we would like to highlight some points a negotiator shall pay attention for while translating or performing translation review.

Terms of law. Terms of law shall be translated exactly as they are used in the same meaning in the local legal acts. This may sound self-evident, however if a translator has no legal background or didn’t work much with clinical trial agreement translation, some errors are possible, and the local negotiator must detect and correct them at template stage.

GCP terminology. Countries have their own adoptions of GCP which are somehow incorporated into the local legislation (as national standard, legal act, order etc.). This means official GCP translation shall be available, thus translation of all GCP terms used in the English version of a clinical trial agreement shall strictly correspond the local-language CGP in all applicable cases.

Budget translation. Budget items (procedures) listed in the budget annex of the clinical trial agreement are usually taken from the schedule of events of the final study protocol. In majority of cases local translation of the protocol is required for regulatory submission, and this translation will most likely be used by local investigators to conduct the trial. Thus, it is strongly recommended to translate procedure names as they are in the translated protocol.

So, we see, excessive creativity while translating a clinical trial agreement may result in re-inventing the wheel (best case) or even making mistakes (worse case). It doesn’t mean, of course, that translation of clinical trial agreement is something that shall be performed ‘mechanically’, yet it shall be identical to the content worded in English and correspond to the local reality.

Again, it is a good example that the global approach shall always be adjusted to the local knowledge. This is exactly what we, CTA Focus, keep doing every day.