Study Start-Up & Essential Documents - UC Davis Health System

Initiation VisitTakes place after site has received first shipment ofclinical supplies, & usually prior to any subject enrollment‣ The following topicswill be reviewed:‣ Drug inventory‣ Study protocol‣ Administrative binder‣ Adverse event reportingprocedures‣ Good Clinical Practice‣ Source documentation‣ Record Retention‣ Procedures for completion ofworkbooks‣ Recruitment strategies‣ Monitoring procedures18