The moment an investigator-initiated clinical drug trial with a medicinal product is submitted to the EC, HIRUZ CTU contacts the principal investigator to plan the trial initiation visit (TIV). During the TIV all procedures will be explained, mutual responsibilities will be determined, scheduling of monitoring visits will be discussed, management of the Investigator Site file (and Trial Master file) will be discussed… A TIV has to be executed prior to the start of the trial (the first patient being screened) and after EC/FAMHP approval is obtained.