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 performance study is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study.
Chun a áirithiú go ndéanfar cearta, sábháilteacht agus dea-bhail na n-ábhar a chosaint, agus go bhfuil déanamh an staidéir feidhmíochta i gcomhréir le ceanglais an Rialacháin seo, áiritheoidh an t-urraitheoir go ndéanfar faireachán leordhóthanach ar dhéanamh an staidéir feidhmíochta.