Recruitment

  • Published by Viedoc System 2023-06-21
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Recruitment

You can sort the data to focus on recruitment status by country, site, or subject, with the following columns showing, respectively:

by Country

  • Study, Country, Total
  • Screened: Current, Expected, Max allowed, DLS
  • Enrolled: Current, Expected, DLE, ER/week, ER/month
  • Candidate, Ongoing, Completed, Withdrawn, SFR %, DOR %, # of sites

by Site

  • Study, Country, Site Code, Site Name, Total
  • Screened: Current, Expected, Max allowed, DLS
  • Enrolled: Current, Expected, DLE, ER/week, ER/month
  • Candidate, Ongoing, Completed, Withdrawn, SFR %, DOR %, # of sites

by Subject

  • Study, Country, Site Code, Site Name, Subject, Screened, Enrolled, Candidate, Ongoing, Completed, Withdrawn, Reason for withdrawal

by Subject (with dates)

  • Study, Country, Site Code, Site Name, Subject, Screened, Screened date, Enrolled, Enrolled date, Candidate, Ongoing, Completed, Completed date, Withdrawn, Withdrawn date, Reason for withdrawal

The definition of the recruitment report, based on the following subject status definitions being met in Viedoc Designer, is as follows:

Note! The subject status definitions are as defined in the individual study on the Study settings page.

  • Screened - if ScreenedState = TRUE
  • Enrolled - if EnrolledState = TRUE
  • Completed - if CompleteState = TRUE
  • Withdrawn - if WithdrawnState = TRUE
  • Candidate - if !ScreenedState and CompleteState != TRUE and WithdrawnState != TRUE
  • Ongoing - if ScreenedState and CompleteState != TRUE and WithdrawnState != TRUE
  • ScreenFailed - if WithdrawnState = TRUE and EnrolledState != TRUE
  • Dropout - if WithdrawnState = TRUE and EnrolledState = TRUE

These flags are summarized at site and country level, and the following values are calculated:

  • DLS - Days since latest screening - the number of days since the latest ScreenedOnDate
  • DLE - Days since latest enrollment - the number of days since the latest EnrolledOnDate
  • ER/week - Enrollment rate per week - the number of enrolled subjects/elapsed days in weeks
  • ER/month - Enrollment rate per month - the number of enrolled subjects/elapsed days in months
  • Candidate - Added, not yet screened
  • SFR % - Screen failure rate - # of subjects screen failed/# of subjects screened
  • DOR % - Drop-out rate - # of subjects dropped out/# of subjects enrolled
  • ERM (enrollment rate per month) - # of enrolled subjects/elapsed days(elapsed days/30
  • ERW (enrollment rate per week) - # of enrolled subjects/elapsed days/7

Elapsed days is defined as:

  • the difference between the earliest initiated event date until the current date, if the enrollment is not yet completed.
  • the difference between the earliest initiated event date until the last subject enrolled date if the enrollment is completed.

Below you will find a detailed descriptions of different sub reports.

Study/Country/Total/Site Code

Sub report Description
Study The name of the study.
Country The country-level location where the study takes place.
Total The total number of subjects.
Site Code The code for the site. (Applies only to Site, Subject, and Subject (with dates) sub reports).

Screened Current

Sub report Description
Country The total number of subjects with ScreenState 'Yes'.
All sub reports are defined in the study design.
Site
Subject
Subject (with dates)

Screened Expected

Sub report Description
Country The Admin defines 'Screened - Expected' in the Study Settings based on individual sites.
Site

Screened - Max allowed

Sub report Description
Country The Admin defines 'Screened - Max allowed' in the Study Settings based on the site.
Site

Screened DLS

Sub report Description
Country Days since latest screening - The number of days since the latest screened date. The date is set by the location of the site.
Site

Screened SF

Sub report Description
Country Screen failure - The subjects screened and withdrawn and not enrolled.
Site

Screened SFR%

Sub report Description
Country Screened failure rate - If 'Screened - Current' is 0 then the SFR% is 0.
If 'Screened - Current' is over 0, then the result is rounded to the first decimal point.
Site

Enrolled Current

Sub report Description
Country In the Country and Site sub reports, the total is the sum of EnrolledState 'Yes'.
All sub reports are defined in the study design.
Site
Subject
Subject (with dates)

Enrolled Expected

Sub report Description
Country The Admin defines 'Enrolled - Expected' in Study Settings based on the site.
Site

Enrolled DLE

Sub report Description
Country Days since latest enrolment - The number of days since the latest EnrolledOnDate. The date is set by the location of the site.
Site

Enrolled ER/Week

Sub report Description
Country Enrolment rate per week (ER/week) - The 'Enrolled - Current' / (elapsed days / 7). The quotient is rounded to the first decimal point.
Site

Enrolled ER/Month

Sub report Description
Country Enrolment rate per month (ER/month) - The 'Enrolled - Current' / (elapsed days / 7). The quotient is rounded to the first decimal point.
Site

Enrolled DO

Sub report Description
Country Drop-out - Subjects enrolled and withdrawn.
Site

Enrolled DOR%

Sub report Description
Country Drop-out rate - The 'Enrolled DO' / 'Enrolled Current'.

If 'Enrolled - Current' is 0 then the DOR is 0.

If 'Enrolled - Current' is greater than 0, then the result is rounded to the first decimal point.
Site

Total Candiate

Sub report Description
Country The total number of subjects not screened and not withdrawn and not completed.
Site
Subject
Subject (with dates)

Total Ongoing

Sub report Description
Country The total number of subjects screened and not withdrawn and not completed.
Site
Subject
Subject (with dates)

Total Completed

Sub report Description
Country The total number of subjected Completed as defined in the study design.
Site
Subject
Subject (with dates)

Total Withdrawn

Sub report Description
Country The total number of subjects withdrawn as defined in the study design.
Site
Subject
Subject (with dates)

Reason for Withdrawal

Sub report Description
Subject The reason a subject has withdrawn from a study.
Subject (with dates)

Screened/Enrolled/Completed/Withdrawn Dates

Column Sub report Description
Screened Date Subject (with dates) Defined in the study design. The date is taken from the event date form. Add (UTC) or (local time) where applicable.
Enrolled Date Subject (with dates)
Completed Date Subject (with dates)
Withdrawn Date Subject (with dates) Defined in the study design. The date is taken from with the reason for withdrawal is saved.

Note! The subject status definitions are as defined in the individual study on the Study settings page.