Economic facts relating to the testing of new medicinal products or medicinal products not newly established
The sponsor or research fund holder must provide the IRCCS MultiMedica with equipment and inventoryable material not in possession of the facility, consumables and, of course, medicines to be used in the trial.
The sponsor or research fund holder shall not provide that material which does not constitute additional expenditures for the purpose of the trial, is part of the established treatments and interventions provided in the trial.
The sponsor or research fund holder shall ensure adequate insurance cover for trial subjects. The insurance cover is intended to protect subjects from any damage directly or indirectly resulting from the trial.
The sponsor or research fund holder must provide insurance cover for investigators.
The sponsor or research fund holder may not engage in direct bargaining with health care or administrative personnel involved in the trial. The negotiations must be conducted directly with the Institution.
The sponsor or research fund holder must send the necessary medicines for the trial directly to the institution’s pharmacy. The person in charge of the pharmacy will register and store the drugs and deliver them to the investigator.