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• For each location, the number of screened, screened failed, randomized, withdrawn and complete subjects, as well as the screening and randomization limit.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 and View Form Data for Subjects permissions can generate this report.

Filters

Filter	Description
Include Audit Trail	Choose one of the following: Yes to see the current values plus all historical changes to them. No to see only the current value.
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: HTML PDF XLSX Note: For the XLSX format, each section of the report has its own sheet.

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, Screen Failure, Completed, and Withdrawal.
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. Note: Subjects that have been selected for replacement randomization are not counted towards the total number of randomized subjects.
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, under a Stratum combination.
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.