A detailed description of the clinical procedures and diagnostic tests used in the course of the clinical investigation and in particular information on any deviation from normal clinical practice.
Tuairisc mhionsonraithe ar na nósanna imeachta cliniciúla agus na tástálacha diagnóiseacha a úsáideadh le linn an imscrúdaithe chliniciúil agus, go háirithe, faisnéis faoi aon diall ó ghnáthchleachtas cliniciúil.