2。General principles ................................................................................... 5 2.1.确保试验参与者的安全........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... 5 2.2。Factors that contribute to a conclusion that the safety profile of a drug is sufficiently characterised to justify selective safety data collection ............................................... 5 2.3.Baseline data ............................................................................................ 7 2.4.Data that should generally be collected ............................................................ 7 2.5.Data that may be appropriate for selective collection ........................................... 7 2.6.Benefit-risk considerations for selective safety data collection ................................ 8 2.7.Early Consultation with Regulatory Authorities ................................................... 8 2.8.可以考虑选择性安全数据收集的情况................................................................................................................................................................................................................................................................................................................................................................................. 8