Management activities of the ethical-administrative authorization process for clinical studies.

  • Management of the requests for changes and clarifications by the Ethic Committee and Competent Authorities;
  • Compiling of the Clinical Trial Application (CTA) Form for the submission of the authorization request, and amendment;
  • Insertion of data in the OsSC- Osservatorio Nazionale per la Sperimentazione Clinica dei Medicinali and Observational Studies Register – RSO (opening and closing of the centres, conclusion of the study, insertion of the final results);
  • Activities to evaluate the safety profile of the drug in the study by collecting, monitoring and analysing the serious adverse events (SAE) and the SAE queries;
  • Management and reporting of suspected and unexpected serious adverse reactions (SUSAR) to Ethics Committees, Experts and Competent Authorities (through EudraVigilance);
  • Preparation and submission of the Development Safety Update Report (DSUR) to the Ethics Committees and competent authorities.