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- Candidate, Ongoing, Completed, Withdrawn, SFR %, DOR %, # of sites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- Candidate, Ongoing, Completed, Withdrawn, SFR %, DOR %, # of sites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- Study, Country, Site Code, Site Name, Subject Sequence, Subject, Screened, Enrolled, Candidate, Ongoing, Completed, Withdrawn, Reason for withdrawal
by Subject (with dates)
- Study, Country, Site Code, Site Name, Subject Sequence, Subject, Screened, Screened date, Enrolled, Enrolled date, Candidate, Ongoing, Completed, Completed date, Withdrawn, Withdrawn date, Reason for withdrawal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- Withdrawn - if WithdrawnState = TRUE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.
