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2.9 Trial Management

In this section, enter information about the number of trial management staff, travel information such as trips made to the trial site, proportion of staff working from home, and time spent on-site per staff visit.

Trial management staff are staff who oversee the entire trial across multiple sites, and who are responsible for its overall planning, execution and coordination, such as trial managers, data managers and trial statisticians.

tip

Organisations may use different terms for similar clinical trial roles and activities. If you are unclear on the definition of any terms used in the calculator, check the glossary for commonly accepted definitions

Do you want to enter individual country profiles?​

Here you have the option to enter different travel profiles for each country defined in the trial.

If you select 'No' that you do not wish to enter individual country profiles you will fill in the information once.

If you select that 'Yes' you would like to enter individual country profiles, all countries that you have entered in section 2.2 will appear in a table for you to add the relevant information in for.

Staff time​

Total staff hours​

In this field you need to enter the total time in hours that all staff work on the trial for the entire duration of the trial. If you are unsure you can click on 'use approximate value' for default data.

Using an approximate value will lower the confidence score rating on the results page.

Proportion spent working from home (percentage)​

In this field you can enter the proportion of time that staff will work from home for the duration of the trial. If you are unsure you can click on 'use approximate value' for default data.

Using an approximate value will lower the confidence score rating on the results page.

Staff commuting​

Total number of management staff involved in trial​

In this field you need to enter the number of management staff involved in the trial for its duration.

Staff trips to trial site​

This is the total number of round trips to the trial site for each member of staff for the entire duration of the trial.

Do you have staff travel data?​

If you select 'No' the table will show the default travel mode value, this can affect the confidence score when calculating results.

If you select 'Yes' you are able to enter percentage averages for each mode of transport. A blue progress bar will assist to ensure all data entered equals 100%

The transport options available are:

  • Aeroplane (domestic)
  • Aeroplane (long haul)
  • Bike / Walk
  • Bus
  • Car
  • Coach
  • Electric Car
  • Light Rail / Tram
  • National Rail
  • Taxi
tip

Long-haul flights are defined as journeys covering a distance of 7,400 km or more.

Do you know the average round trip distance travelled?​

In this field you need to enter the average round trip distance travelled, if you select 'yes' then when you enter an average trip distance you have the option to choose miles or kilometres (km) from the dropdown.

If you select 'no' that you do not know the average round trip distance traveled, then an approximate value will be entered which will lower the confidence score rating on the results page

note

Note: If you have specified that your trial takes part in different countries you will have to repeat the process for each country's travel profile.

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