Protocol review and provision of medical comments

Protocol training for the biotech study team and CRO CRAs

Eligibility review and approval

Sponsor Medical review of Individual Case Safety Report (ICSR), Analysis of Similar Events (AOSE), and Reference Safety Information (RSI)

Medical review of applicable data: review data listings and issue medical queries to the database after CRO review. The review will be done quarterly and include safety, lab and ECG data. If deemed necessary, the medical monitor will follow up with the investigator via email or phone to ensure that issues are managed in an appropriate medical and scientific manner

Medical review of coding: review MedDRA coding and ATC allocation of WHO drug coding to ensure medical coding accuracy as per CRO SOP. The review will be done quarterly after CRO review and include coding adverse events, medical history and concomitant medications

Protocol deviation list review

Review of clinical study report (CSR) and recommendation