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Table 1 Minimum facilities required to hold a Lassa fever vaccine trial

From: A systematic scorecard-based approach to site assessment in preparation for Lassa fever vaccine clinical trials in affected countries

     

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

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Pilot and Feasibility Studies

ISSN: 2055-5784