Common use of Safety Database Clause in Contracts

Safety Database. Omnicare CR will develop the safety database for the Project. The database platform is the current version of the **** safety surveillance system. The system is fully validated and complaint with all regulatory requirements for electronic storage of adverse event data. Additionally, the system is capable of generating adverse event files in electronic format according to the definitions set in ICH E2B. Omnicare CR is able to perform electronic submission of serious, unexpected, suspected adverse reactions (‘SUSARs’) to regulatory authorities as mandated by the European Clinical Trials Directive.