ROLE AND RESPONSIBILITIESMedical guidance to site personnel and the project team regarding Protocol and other study-specific medical aspects24/7 medical consultancy support to investigators and project teamMonitoring of patient’s safety and well-being: Detection of trends and outliers Signal detectionEligibility checkReview of selected laboratory parameters Protocol deviations review with proposed grading from medical/safety perspective Review of subject discontinuation listMonitoring of specific safety parameters (risks due to IMP or AxMP safety profile as well as an indication)Medical review/creation of case/narratives and participating in the SAE reconciliation as support to the Safety Department Regular presentations of MM reports to the study teamMedical Review of patient dataMedical input to the study-related documents (including the preparation of the MM plan)Participation in Kick-off Meetings, Investigator Meetings, and other study-related meetings, including participation at the safety committee meetings (DSMB, IDMC, and SRC meetings) andPresentation of the safety dataTraining of the project team and investigators on the indication, IMP, AxMP, and other medical aspects of the studyReviews or assists in the review of medical coding to assure congruency with the terms reported in the case report form (CRF) and provides re-coding of events if appropriateOverview of SP activities and review of the SP visit reports
