Program Objectives
-
Act as Medical Monitor of Biotech that is conducting a clinical trial -
Evaluate the relatedness to the investigational product or seriousness of the adverse events that occurred during
the clinical trial, and lead conclusion through medical & scientific discussion with investigators -
Discuss or decide various medical issues with investigators and/or CRO to facilitate the smooth progress
of the clinical trial
Work Scope of Medical Monitor
-
01Protocol review and provision of medical comments
-
02Protocol training for the biotech study team and CRO CRAs
-
03Eligibility review and approval
-
04Sponsor Medical review of Individual Case Safety Report (ICSR), Analysis of Similar Events (AOSE), and Reference Safety Information (RSI)
-
05Medical 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
-
06Medical 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
-
07Protocol deviation list review
-
08Review of clinical study report (CSR) and recommendation
If you have any questions, please email contactus@medirama.co.kr