If a sponsor intends to introduce modifications to a clinical investigation that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation, it shall notify, within one week, by means of the electronic system referred to in Article 73 the Member State(s) in which the clinical investigation is being or is to be conducted of the reasons for and the nature of those modifications.
Má tá sé ar intinn ag urraitheoir modhnuithe a dhéanamh ar imscrúdú cliniciúil ar cosúil go mbeidh tionchar substaintiúil acu ar shábháilteacht, ar shláinte nó ar chearta na n-ábhar don imscrúdú nó ar stóinseacht nó ar iontaofacht na sonraí cliniciúla a ghinfear san imscrúdú, tabharfaidh sé fógra, laistigh de sheachtain, tríd an gcóras leictreonach dá dtagraítear in Airteagal 73, don Bhallstát nó do na Ballstáit ina bhfuil an t-imscrúdú cliniciúil á dhéanamh, nó inambeid hsé le déanamh faoi na cúiseanna atá leis na modhnuithe sin agus a bhfuil i gceist leo.