Determine whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the Ethic Committees (IRB/IEC), Sponsor and the applicable regulatory requirement(s) Ensure deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements are documented and communicated appropriately and take appropriate action to prevent recurrence of the detected deviations. The Clinical Research Associate (CRA) is responsible for the oversight of assigned investigative sites in accordance with all applicable protocols, project plans, Sponsor SOPs, GCP guidelines, and regulatory requirements from site initiation through site close out.