Issue link: http://sarahcannon.uberflip.com/i/1542905
Meeting Minutes Doc. No.: IBC-FORM-19 V.01.4 Page 3 of 4 Effective Date 04 AUG 2025 o The Site confirmed that only study personnel who have been educated on the potential biohazards and the precautions to be taken when working with the IP will handle the IP or any materials contaminated by the IP. o The Site confirmed that study personnel are sufficiently trained in the practices and techniques required to safely work with the IP. o The Site confirmed that staff members receive Bloodborne Pathogens training. o Occupational Health Recommendations: Staff who are pregnant or breastfeeding, immunocompromised, or have ongoing inflammatory skin conditions or severe eczema should not handle preparing the study agent. Staff who have open wounds or cuts which may be exposed to the agent should consider consulting with the PI or occupational health prior to handling the study agent. o The Committee had no additional significant comments or recommendations regarding the description of the potential risks and occupational exposure hazards associated with handling the IP in this clinical trial, or the proposed mitigation strategies, as detailed in the Risk Assessment. • The Committee reviewed the Site's facility details, relevant study-specific procedures and practices and other applicable information provided by the Site for the purposes of the IBC review. o The Chair reviewed the Change in Research to add a new dosing location. o The Site verified that the information provided by the Chair was accurate. o The Committee noted that the Biosafety Cabinet (BSC) Certifications will expire by the end of the month and reminded the Site to provide updated copies of the Certification reports when they become available. The Site confirmed that the BSCs were certified recently and are awaiting the updated certificates. o The Committee noted that the BSCs did not have biohazard stickers affixed to them. The Committee stipulated that the Site affix biohazard stickers on the BSCs and provide an updated photo. o The Committee noted that biohazard stickers were not present on the sharps and biohazard bins in the Interventional Radiology rooms. The Committee stipulated that the Site affix biohazard stickers on the bins and provide an updated photo. Motion: A motion of Approval with Stipulations for the study at BSL-2 was passed by unanimous vote. There were no votes against and no abstentions. • Contingencies stated by the Committee: None • Stipulations stated by the Committee: o The Committee stipulated that the Site affix biohazard stickers on the biosafety cabinets and provide an updated photo of a BSC by 2-20-26. The Committee agreed that resolution of this stipulation can be approved following review by the AP.