What's included

What goes into the IB

• Initial IB drafting, structured to the ICH-recommended format from the first study data package
• Scheduled updates that incorporate new findings from ongoing monitoring and safety review
• Safety sections built in coordination with aggregate reporting, so the IB and periodic safety reports never diverge
• Version control across amendments so every site is working from the current approved IB
• Consistency review against the protocol and informed consent forms referencing the same risk information