Raziskovalec se mora seznaniti z zaključki farmakoloških in toksikoloških študij in vlagatelj mu mora predložiti vsaj brošuro za raziskovalca, ki je sestavljena iz vseh pomembnih informacij, ki so znane pred začetkom kliničnega preskušanja, vključno s kemijskimi, farmacevtskimi in biološkimi podatki, toksikološkimi, farmakokinetičnimi in farmakodinamičnimi podatki pri živalih ter rezultati prejšnjih kliničnih preskušanj, z ustreznimi podatki, ki utemeljujejo vrsto, obseg in trajanje predlaganega preskušanja;
The investigator must acquaint himself with the conclusions drawn from the pharmacological and toxicological studies and hence the applicant must provide him at least with the investigator's brochure, consisting of all the relevant information known prior to the onset of a clinical trial including chemical, pharmaceutical and biological data, toxicological, pharmaco-kinetic and pharmaco-dynamic data in animals and the results of earlier clinical trials, with adequate data to justify the nature, scale and duration of the proposed trial;