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Beag beann ar a dtiocfaidh as an imscrúdú cliniciúil, laistigh de bhliain amháin ó thagann deireadh leis an imscrúdú cliniciúil nó laistigh de thrí mhí ó chuirtear deireadh luath nó stad sealadach leis, déanfaidh an t-urraitheoir tuarascáil ar an imscrúdú cliniciúil amhail dá dtagraítear i Roinn 2.8 de Chaibidil I agus i Roinn 7 de Chaibidil III d'Iarscríbhinn XV a chur faoi bhráid na mBallstát ina raibh imscrúdú cliniciúil á dhéanamh.
Irrespective of the outcome of the clinical investigation, within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a clinical investigation was conducted a clinical investigation report as referred to in Section 2.8 of Chapter I and Section 7 of Chapter III of Annex XV.