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Table 2 Examples of trial set up tasks completed within 1 month and the BTC resource required

From: Delivering COVID-19 vaccine trials at speed: the implementation of a phase IV UK multi-centre randomised controlled trial to determine safety and immunogenicity of COVID-19 vaccines co-administered with seasonal influenza vaccines (ComFluCOV)

Task

BTC resource

 

BTC lead

Trial manager 1

Trial manager 2

Trial manager 3

Trial manager 4

Trial manager 5

Statistician 1

Statistician 2

Database manager 1

Database manager 2

Database manager 3

Protocol development

✔

✔

✔

        

Patient facing materials

✔

 

✔

✔

✔

      

Advertising materials

   

✔

       

Database development

     

✔

✔

✔

✔

✔

 

Randomisation system

     

✔

 

✔

✔

✔

✔

Trial management system

    

✔

     

✔

Regulatory approvals

 

✔

         

Sponsorship/governance

  

✔

        

Training documents

 

✔

✔

✔

✔

✔

     

Pharmacy

  

✔

        

Laboratory/samples

 

✔

         

Monitoring plan

  

✔

        

Site set up

    

✔

      

Statistical analysis plan

✔

     

✔

✔

   
  1. Note: All set up tasks were overseen by the CI and BTC lead. All BTC staff were full time employees
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Trials

ISSN: 1745-6215