Trial Master File Other Training Study staff Trial Informed consent subjects Safety rights and safety In-/exclusion criteria Withdrawal / drop out Concomitant medication Contraindicated medication Degree of intervention Data Data protection Data capture Recording data Data validation Database lock Other Protocol Main endpoints / variables procedures Protocol specified procedures (complexity) Research biobank
Trial Master File Other Training Study staff Trial subjects rights and safety Informed consent Safety In-/exclusion criteria Withdrawal / drop out Concomitant medication Contraindicated medication Degree of intervention Data Data protection Data capture Recording data Data validation Database lock Other Protocol procedures Main endpoints / variables Protocol specified procedures (complexity) Research biobank
NORM_Guideline_for_monitoring_version_5_24.10.2017.docx