- seznam raziskovalca(-ev), vsak raziskovalec pa navede svoje ime, naslov, zadolžitve, usposobljenost in klinične dolžnosti, izjavo o kraju preskušanja ter zbere podatke o vsakem posameznem bolniku, vključno z obrazcem za poročilo o primerih pri vsakem posamezniku, udeleženem v preskušanju,
- the list of investigator(s), and each investigator shall give his name, address, appointments, qualifications and clinical duties, state where the trial was carried out and assemble the information in respect of each patient individually, including case report forms on each trial subject