details of the clinical trial protocol giving a description of the methods used, including methods of randomisation and blinding, details such as the route of administration, schedule of administration, the dose, identification of trial animals, species, breeds or strains, age, weight, sex, physiological status;
sonraí an phrótacail maidir le triail chliniciúil ina dtugtar tuairisc ar na modhanna a úsáideadh, lena n-áirítear modhanna randamúcháin agus dalladh, sonraí cosúil le bealach na tabhartha, an sceideal don tabhairt, an dáileog, sainaithint ainmhithe trialach, speiceas, pórtha nó tréithchineál, aois, meáchan, gnéas, stádas fiseolaíoch;