As a partner of the H2020 STRITUVAD project, Università degli Studi di Catania (UNICT) has access to data of dose versus immunogenicity response in healthy volunteers and patients with active tuberculosis for two therapeutic vaccines (Archivel RUTI and IDRI ID93). In addition, by the time the In Silico World project starts, UNICT will have access also to early response results for RUTI therapy in a phase II interventional trial.
The expected quality of the data will be guaranteed by the procedures described and applied in the clinical trial dossier. In particular, the data entries will be checked and supervised by the monitors for all patients and for all entered data.
The data collected in a database will be kept for a period of 15 years. Clean File for the final database will be declared when all data have been entered and a quality check on a sample of the data has been performed. The database will be locked after Clean File has been declared and data extracted for statistical analysis.