Monitoring Activities

Their dedicated qualified CRAs perform several visits at each site including: initiation visit, onsite monitoring visits and close out visits- end of study visit.

During initiation visit, the protocol and investigational product are presented including the relevant efficacy and safety data. The team responsibilities are defend by the site Principle investigator. Any additional training is being performed such as EDC.

On-site monitoring visits are performed throughout the study to ensure all data collected is accurate, all data queries are resolved, the safety reporting fulfill the required requirements, regulatory documents are updated as necessary, site team members are properly trained and the Investigator’s Site File (ISF) is updated.

During close out visit, the monitor is responsible to make sure that all remaining investigational product, used and un used, was destroyed or return to the sponsor, that the ISF is completed, and that end of study notification was provided by to the local EC and CA