Table 1.

Minimum facilities required to hold a Lassa fever vaccine trial

											Score
Scientific thinking	Design and planning of research	Protocol optimization	Interpretation of study results	What is the total number of scientific staff at the clinical research center?							10
				How many years has this site been in existence?							4
				List 5 more recent publications emanating from research conducted at the site							5
				List top 5 pharmaceutical companies or global health funding agencies you have worked with							5
				Total							24
Study and site management	Study oversight	Human resources	Resources management	What is the total number of non-scientific staff at the clinical research center?							10
				Distance from airport (domestic/international) in kilometers							2
				Is the site accessible by road?							1
				What is the road condition (e.g., dirt, tarmac)?							1
				Administrative offices							1
				Access to reliable internet connection? State type (wifi/DSL/dongle/cable/satellite)							1
				Designated study document storage area and archiving facilities available on site (e.g., archiving room)							1
				Power source with dedicated functional back up available?							1
				Vaccine management (reception, local shipment), cold chain management, destruction, vaccination process, and equipment							1
				Dedicated + 2 and + 8° refrigerators? If yes, indicate how many in spaces below							1
				Access to − 20 °C freezers? If yes, indicate how many in space below							1
				Access to − 70 °C freezers? If yes, indicate how many in space below							1
				Total							22
Research operations	Data management	Clinical and laboratory	Interaction with community and participants	Outpatient care facility							1
				Inpatient care facility for study patients							1
				Examination room(s) for subject evaluation and treatment							1
				Access to laboratory services?							1
				If no laboratories on site, what is the distance between the study/trial site and the laboratory(ies)? (Please indicate miles or kilometers)							2
				List below the different laboratories available such as hematology, clinical chemistry, etc.							6
				Is the laboratory able to conduct immunochemical studies, e.g., RT-PCR?							10
				Does the laboratory have local/national reference ranges?							1
				Dedicated work area for clinical research team							1
				Consenting or counseling room(s)							1
				Presence of or easy access to intensive care unit?							1
				How many kilometers away is the ICU (if not on site)?							1
				Emergency services (e.g., where anaphylaxis can be handled)?							1
Ethics, quality, and risk management	Regulations and governance			Is there an established quality management system in place?							1
				Total							29
										Total	75