Study Enrollment report
In this report, you view details about enrollment for a study.
Details in the report include the following:
- The open or closed status for enrollment for a study, site, country, and cohort.
- For each location, the number of screened, screened failed, randomized, withdrawn and complete subjects, as well as the screening and randomization limit.
- For each cohort, the number of randomized subjects, as well as the randomization limit.
- The total number of subjects that have been randomized in the study.
- The number of subjects that have been enrolled from another study.
This report is particularly useful if you're a member of the study management team. You can run this report whenever you want to see the total enrollment for a given group. The report is an easy way to see count information across multiple groups.
Modes
Available in all 3 modes: Testing, Training, and Production
Permission required to run the report
Any user assigned the Run the Enrollment Report permission can generate this report.
Filters
| Filter | Description |
|---|---|
| Include Audit Trail | Choose one of the following:
|
| Audit Trail Date Range | Choose a date range for the report. The report will include only the sites and depots that were updated during the date range. |
| File Type | Choose the output type for the report:
|
Field descriptions
Note:
Fields that don't have any corresponding values are marked as N/A in the report.| Initial fields | Description |
|---|---|
| Customer Name | A customer's name used to purchase the cloud subscription |
| Study Name | A study's ID as entered by the study manager when they created the study |
| Mode | The mode in which you ran this report. For example, you may run a report in Testing mode to verify the data before going live with your study |
| Include Audit Trail | Setting that indicates if you included audit trails in your report or not |
| Report Generated By | User name of the user who generated this report |
| Create Date | UTC time and date of the current generated report |
| Audit Trail Date Range | Period of time indicated to show the audit trail |
| Fields in General Enrollment | Description |
|---|---|
| Group | Displays the enrollment level: Study Total or Site |
| Enrollment | Indicates whether the enrollment is opened or closed (Opened or Closed) |
| Screening Limit | Numbers of subjects that can be screened in a study |
| Screened Subjects | Number of subjects in a state of New, Screened, and Screen Failed |
| Screen Failed Subjects | Number of subjects with a state of screen failed |
| Randomization Limit | Number of subjects that can be randomized in a study |
| Randomized Subjects | Total number of subjects that have ever been randomized in a study, including those subjects with a status of Withdrawn or Complete |
| Enrolled Subjects | Number of subjects that were enrolled from another study |
| Completed Subjects | Number of subjects with a state of Complete |
| Withdrawn Subjects | Number of subjects with a state of Withdrawn |
| Notification % | Percentage value as to when a notification can be triggered for a specific level |
| Fields in General Enrollment Audit Trail | Description |
|---|---|
| Group | Displays the enrollment level: Study Total or Site |
| Enrollment | Indicates whether the enrollment is opened or closed (Opened or Closed) |
| Screening Limit | Number of subjects that can be screened in the study or site |
| Randomization Limit | Number of subjects that can be randomized in a study or site |
| Notification % | Percentage value as to when a notification can be triggered for a specific level |
| Last Modified | Date of the most recent changes performed by a user |
| Last Modified By | User name of the user who made the latest change |
| Fields in Screening and Randomization by Site | Description |
|---|---|
| Site Name | A site's name |
| Site ID | A site's ID |
| Screening Limit | Numbers of subjects that can be screened in a study |
| Screened Subjects | Number of subjects in a state of Screened |
| Screen Failed Subjects | Number of subjects with a state of screen failed |
| Randomization Limit | Number of subjects that can be randomized in a study |
| Randomized Subjects | Total number of subjects that have ever been randomized in a study, including those subjects with a status of Withdrawn or Complete |
| Enrolled Subjects | Number of subjects that were enrolled from another study |
| Completed Subjects | Number of subjects with a state of Complete |
| Withdrawn Subjects | Number of subjects with a state of Withdrawn |
| Last Modified By | User name of the user who last performed the last change. |
| Fields in Cohort Enrollment | Description |
|---|---|
| Cohorts | Cohorts included in the study |
| Enrollment Randomization Limit | Number of subjects that can be randomized for each cohort |
| Randomized Subjects | Total number of subjects that have ever been randomized in each cohort |
| Notification % | Percentage value as to when a notification can be triggered for a specific level |
| Last Modified | Date of the most recent changes performed by a user |
| Last Modified By | User name of the user who made the latest change |
| Fields in Country Enrollment | Description |
|---|---|
| Countries | Country where subjects are enrolled in the study |
| Enrollment | Indicates whether enrollment is opened or closed (Opened or Closed values) |
| Screening Limit | Number of subjects that can be screened in the study, country, or countries |
| Screened Subjects | Number of subjects with a state of screened |
| Screen Failed Subjects | Number of subjects with a state of screen failed |
| Randomization Limit | Number of subjects that can be randomized in a study, country, or countries |
| Randomized Subjects | Total number of subjects that have ever been randomized in a study, including those subjects with a status of Withdrawn or Complete |
| Enrolled Subjects | Number of subjects that were enrolled from another study |
| Completed Subjects | Number of subjects with a state of Complete |
| Withdrawn Subjects | Number of subjects with a state of Withdrawn |
| Notification % | Percentage value as to when a notification can be triggered for a specific level |
| Fields in Country Enrollment Audit Trail | Description |
|---|---|
| Country | Country where subjects are enrolled in the study |
| Enrollment | Indicates whether enrollment is opened or closed (Opened or Closed values) |
| Screening Limit | Number of subjects that can be screened in the study |
| Randomization Limit | Number of subjects that can be randomized in a study |
| Notification % | Percentage value as to when a notification can be triggered for a specific level |
| Last Modified | Date of the most recent changes performed by a user |
| Last Modified By | User name of the user who made the latest change |
Parent topic: Report descriptions