Program Objectives
  • 임상시험 예정 또는 진행중인 바이오텍의 Medical Monitor 역할을 담당: 업무내역은 아래 참조
  • 바이오텍의 Medical Monitor 로서 임상시험 중 발생된 부작용에 대해 중대성 및 시험약물과의 관련성에 대해 평가하고,
    연구자와 논의하여 결론을 도출함
  • 바이오텍의 Medical Monitor 로서 연구자들이나 CRO 와 여러가지 의학적 이슈들을 논의 및 결정하여 임상시험의 원활한
    진행을 촉진함
Work Scope of Medical Monitor
  • 01
    Protocol review and provision of medical comments
  • 02
    Protocol training for the biotech study team and CRO CRAs
  • 03
    Eligibility review and approval
  • 04
    Sponsor Medical review of Individual Case Safety Report (ICSR), Analysis of Similar Events (AOSE), and Reference Safety Information (RSI)
  • 05
    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
  • 06
    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
  • 07
    Protocol deviation list review
  • 08
    Review of clinical study report (CSR) and recommendation
My MD 에 대한 문의사항은로 메일 주시기 바랍니다.