Issue link: http://sarahcannon.uberflip.com/i/1546055
Meeting Minutes Doc. No.: IBC-FORM-19 V.01.4 Page 3 of 4 Effective Date 04 AUG 2025 o The Site confirmed that staff members receive Bloodborne Pathogens training. o Occupational Health Recommendations: Staff who are immunocompromised, pregnant, breast-feeding, or have severe inflammatory skin conditions are recommended to be excluded from handling or preparing VET3-TGI and should consult with the Principal Investigator or their respective Occupational Health department prior to handling the study agent or materials contaminated with 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, the Annual Review Report and other applicable information provided by the Site for the purposes of the IBC review. o The Site confirmed that the information provided in the annual review report form remains accurate. o The Site verified that the summary of the Site's arrangements for storage, preparing and administering the study agent, as provided by the Chair, was accurate. The Site noted that a handwashing sink is also present inside Procedure Poom 1, in addition to the sink in the anteroom. The Site further noted that staff would use the sink in the restroom adjoining Procedure Room 2 to wash their hands following study administration and removal of PPE. The Committee asked that the Site Map and Facility Details form be administratively revised to include the extra sink inside procedure room 1 and the handwashing procedures when using Procedure Room 2 for IP administration. o In response to a question from the Committee, the Site noted that when preparing IP for non-imaging studies, dosing needles are primed in the Biosafety Cabinet (BSC). The Site clarified that when preparing study agent for imaging studies, prepared syringes are capped with a Leur-lock safety cap inside the BSC and transported to the imaging facility where the appropriate dosing needle is attached. The Facility Details form will be administratively updated to reflect these details. o The Committee noted that Sponsor instructions state that for intratumoral (Itu) injections, the dosing needle should be primed with saline prior to agent injection followed by a normal saline flush to conclude the procedure. The Committee recommended that priming be done according to institutional practices to mitigate risk to personnel of exposure to study agent. The Site confirmed these practices are followed. o In response to a question from the Committee, the Site stated there are several refrigerators present in the Pharmacy that could be used to store prepared study agent if needed, although to date refrigerated or room temperature storage of study agent has not been necessary. The Committee asked the Site to ensure that any refrigerator used to store study agent is labeled with a biohazard symbol. The Site stated they believe that their refrigerators are already labeled with a biohazard sticker but will confirm this. The