In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the clinical investigation is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a clinical investigation.
Chun a áirithiú go ndéanfar cearta, sábháilteacht agus dea-bhail na n-ábhar a chosaint, agus go ndéanfar an t-imscrúdú cliniciúil i gcomhréir le ceanglais an Rialacháin seo, áiritheoidh an t-urraitheoir go ndéanfar faireachán leordhóthanach ar an gcaoi a ndéantar imscrúdú cliniciúil.