The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the investigation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation.
Ceapfaidh an tUrraitheoir monatóir a bheidh neamhspleách ar an láthair imscrúdaithe chun a áirithiú go ndéanfar an t-imscrúdú a chur i gcrích i gcomhréir leis an PIC, le prionsabail an dea-chleachtais chliniciúil agus leis an Rialachán seo.