1. Type of facility: Outpatient medical office Hospital Other, please specify: 2. Please identify the facility’s Biosafety Level: BL-1 (handles study products which do not cause disease in healthy humans) BL-2 (handles study products with moderate potential hazard to personnel and the environment that may cause mild disease to humans, or are difficult to contract via aerosol in a lab setting) BL-3 (handles study products involving various microbes which can be transmitted by aerosols and/or cause severe disease) BL-4 (handles study products that are easily transmitted and can cause fatal disease) 3. What study activities will be done at this site? (check all that apply) Biological product receiving or shipping Biological product storage Biological product preparation Dosing Specimen collection Subject medical care or follow-up Other, please specify: 4. Please describe or attach information about the facility environment which supports how the facility contains or reduces exposure to the biological product. (check all that apply) Facility floor plan List of safety equipment (e.g., personal protective equipment, biosafety cabinets) Please specify: Facility design (e.g., hand washing station, autoclave, ventilation system, door locks) Please specify: Other, please describe: 5. How many people will have access to the biological product from the clinical trial at this facility? F. TRAINING & RESOURCES 1. Are there policies in place to ensure that the research site is in compliance with the NIH Guidelines (i.e., Waste Disposal, Spill Procedure, Serious Adverse Event Reporting)? Yes No*, please explain: *Sample procedures are available on the OnQ Portal at www.QuorumReview.com 2. Has research personnel involved in this trial undergone training relative to the NIH Guidelines? Yes No, please explain: 4. Does the research site have a health surveillance program for laboratory workers conducting research with recombinant or synthetic nucleic acid molecules? Yes No, please explain:
1. Type of facility: Outpatient medical office Hospital Other, please specify: 2. Please identify the facility’s Biosafety Level: BL-1 (handles study products which do not cause disease in healthy humans) BL-2 (handles study products with moderate potential hazard to personnel and the environment that may cause mild disease to humans, or are difficult to contract via aerosol in a lab setting) BL-3 (handles study products involving various microbes which can be transmitted by aerosols and/or cause severe disease) BL-4 (handles study products that are easily transmitted and can cause fatal disease) 3. What study activities will be done at this site? (check all that apply) Biological product receiving or shipping Biological product storage Biological product preparation Dosing Specimen collection Subject medical care or follow-up Other, please specify: 4. Please describe or attach information about the facility environment which supports how the facility contains or reduces exposure to the biological product. (check all that apply) Facility floor plan List of safety equipment (e.g., personal protective equipment, biosafety cabinets) Please specify: Facility design (e.g., hand washing station, autoclave, ventilation system, door locks) Please specify: Other, please describe: 5. How many people will have access to the biological product from the clinical trial at this facility? F. TRAINING & RESOURCES 1. Are there policies in place to ensure that the research site is in compliance with the NIH Guidelines (i.e., Waste Disposal, Spill Procedure, Serious Adverse Event Reporting)? Yes No*, please explain: *Sample procedures are available on the OnQ Portal at www.QuorumReview.com 2. Has research personnel involved in this trial undergone training relative to the NIH Guidelines? Yes No, please explain: 4. Does the research site have a health surveillance program for laboratory workers conducting research with recombinant or synthetic nucleic acid molecules? Yes No, please explain:
F-209-001-Institutional-Biosafety-Committee-Questionnaire-19Mar2018.docx