Pharmacokinetic (include only if applicable) Evaluations Safety Evaluations Primary measurements that will be used to assess safety Statistical And Analytic Limit to discussion of analysis to primary endpoint and possibly Plan main secondary endpoint Data And Safety Describe how is responsible for data quality management and Monitoring Plan ongoing assessment of safety: PI, independent medical monitor, internal safety committee, or DSMB
Pharmacokinetic Evaluations (include only if applicable) Safety Evaluations Primary measurements that will be used to assess safety Statistical And Analytic Plan Limit to discussion of analysis to primary endpoint and possibly main secondary endpoint Data And Safety Monitoring Plan Describe how is responsible for data quality management and ongoing assessment of safety: PI, independent medical monitor, internal safety committee, or DSMB