Establishing a system-wide assessment of risk process for investigational drugs

The IP AOR process demonstrates the essential role of pharmacists in operationalizing USP <800> requirements for investigational drugs. This model supports occupational safety, regulatory compliance, and scalable implementation across health systems engaged in clinical research. The process outlined in this manuscript is applicable to both investigational agents and any newly marketed drugs being brought into an institution that haven't been reviewed by NIOSH for inclusion on their list.