CLINICAL OPERATIONS

—Sites Selection

—Creation of monitoring tools, worksheets and status tables (regulatory documents, recruitment, monitoring visits, adverse events, etc.)

—Submission to EC and CA

—Contact with the Investigator site teams (hospital unit, pharmacy, local laboratory)

—Sites Initiation

—Site monitoring visits

—Visit reports, Management of serious adverse events (SAEs), Query management

—Follow up contact with the Investigator site teams

—Management of amendment and notifications to EC and CA

—Site close out visits (Final visit reports)

—Notification of End of Study to EC and CA