The Sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 80(2) are reported by the investigator or investigators to the sponsor in a timely manner.
Beidh comhaontú i bhfeidhm ag an Urraitheoir chun a áirithiú go ndéanfaidh an t-imscrúdaitheoir nó na himscrúdaitheoirí aon tarlú díobhálach tromchúiseach nó aon tarlú eile dá dtagraítear in Airteagal 80(2) a thuairisciú don urraitheoir go tráthúil.