ANNEX IV附則
ANNEX IV NOTIFICATION OF SERIOUS ADVERSE EVENTS Text of image PART A Rapid notification for suspected serious adverse events Tissue establishment Report identification Reporting date (year/month/day) Date of serious adverse event (year/month/day) Serious adverse event, which may affect quality and safety of tissues and cells due to a deviation in: Specification Tissues and cells defect Equipment failure Human error Other (specify) Procurement Testing Transport Processing Storage Distribution Materials Others (specify) PART B Conclusions of Serious Adverse Events investigation Tissue establishment Report identification Confirmation date (year/month/day) Date of serious adverse event (year/month/day) Root cause analysis (details) Corrective measures taken (details)