overall synopsis of the clinical performance study, its design type, such as observational, interventional, together with the objectives and hypotheses of the study, reference to the current state of the art in diagnosis and/or medicine;
achoimriú foriomlán ar an staidéar ar fheidhmíocht chliniciúil, cineál a dheartha amhail cineál breathnaitheach nó idirghabhálach, mar aon le cuspóirí agus hipitéisí an staidéir agus tagairt do staid reatha na teicneolaíochta i gcúrsaí diagnóise agus/nó leighis;