General information such as type of investigation with rationale for choosing it, for its endpoints and for its variables as set out in the clinical evaluation plan.
Faisnéis ghinearálta amhail cineál an imscrúdaithe agus an réasúnaíocht atá lena roghnú, lena chríochphointí agus lena athróga mar a leagtar amach iad sa phlean don mheastóireacht chliniciúil.