The Site Initiation Visit (SIV) is a meeting arranged and conducted by Sponsor team or its delegate to train the study personnel on the study procedures and Good Clinical Practice and regulatory requirements. The SIV is the last step before the start of the trial. After the following condition have been met, is it possible to schedule a SIV and open the site:
• Ethic Commettee approval;
• Signed Clinical Trial Agreement;
• Insurance;
• Greenlight from Research and Development Department or equivalent (if applicable);
• Trial Master File/ Investigator Site File shipped to the site;
• Investigational product shipped to the site (if applicable).