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Subject Enrollment Status by Site

This report shows the number and percentage of subjects screened, enrolled, randomized, active, completed, or dropped by site.

Graphs

A bar graph appears on the first page of the Subject Enrollment Status by Site report, illustrating the number of screened, enrolled, and dropped subjects at each site.

Subtotals and totals

Column descriptions

Column descriptions

Column

Description

Country

Data type: String

Description: The country in which a site is located, as entered in the InForm Administration interface.

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

Site Mnemonic

Data type: String

Description: An abbreviation that identifies a site, as entered in the InForm Administration interface.

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

Screened

Data type: Numeric

Description: The number of subjects who have been successfully screened in the InForm application without a screen failure during the screening process.

How calculated: For each site, counts each subject who was successfully screened without a screen failure during the screening process and who meets one of the following conditions:

  • The enrollment process was not started.
  • The enrollment process was started but not completed because either an enrollment failure occurred or the user completed the enrollment form but chose not to enroll the subject.
  • The enrollment process was completed successfully and the subject moved on to another state (Enrolled, Randomized, Dropped Out, or Incomplete).

UUID: PF_SC_COMPLETECTL

Data source: Derived for the report; not stored in the Reporting and Analysis database.

Screen Failure

Data type: Numeric

Description: The number of subjects who failed the screening process in the InForm application. These subjects have screen failure text generated.

How calculated: For each site, counts the number of subjects that were failed during the InForm screening process. This count excludes the Screen Override values.

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

Enroll Failure

Data type: Numeric

Description: The number of subjects who were successfully screened (no screen failure reason generated), but failed the enrollment process by entering an invalid character (hyphen or a slash). The failure generates the enroll failure reason in the InForm application.

How calculated: For each site, counts the number of subjects who failed the InForm enrollment process. This count excludes the Enroll Override values.

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

Screen Override

Data type: Numeric

Description: For each site, the number of subjects who have been screened in the InForm application due to the screening override process.

How calculated: For each site, counts the number of subjects who failed the InForm screening process and subsequently were screened through the InForm screening override process. This count includes subjects who may have moved on to other states (such as Enrolled, Randomized, Dropped out, or Complete).

Subjects screened and enrolled through PF Admin Import: Subjects who were added to the study through PF Admin Import are not counted in Screen/Enroll Override counts, even if they initially failed screening or enrollment.

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

Enroll Override

Data type: Numeric

Description: For each site, the number of subjects who have been enrolled in the InForm application due to the enrollment override process within the specified date range on the report prompt page.

How calculated: For each site, counts subjects who have ever failed the InForm enrollment process, but have subsequently been enrolled through the InForm enroll override process. This count includes subjects who may have moved on to other states (such as Randomized, Dropped out, or Complete).

Subjects screened and enrolled through PF Admin Import: Subjects who were added to the study through PF Admin Import are not counted in Screen/Enroll Override counts, even if they initially failed screening or enrollment.

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

Enrolled

Data type: Numeric

Description: The number of subjects that were ever enrolled at the site.

How calculated: For each site, the count includes subjects who were initially screen failed or enroll failed but subsequently enrolled or moved from the Enrolled state to other states (Randomized, Dropped out, or Completed).

Subjects screened and enrolled through PF Admin Import: Subjects who were added to the study via PF Admin Import are not counted in Screen/Enroll Override counts, even if they initially failed screening or enrollment.

UUID: PF_SC_COMPLETECTL

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database. Percentage is derived for display.

Randomized

Data type: Numeric

Description: The number of enrolled subjects who have been randomized in the InForm application.

How calculated: For each site, counts subjects who have ever been in the randomized state.

UUID: PF_SC_COMPLETECTL

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database. Percentage is derived for display.

Active in Trial

Data type: Numeric

Description: For each site, the number of subjects currently participating in the study as of the report run date.

How calculated: For each site, counts every subject in the Enrolled or Randomized state within the specified date range. Excludes subjects in the Completed or Dropped out state.

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

Completed

Data type: Numeric

Description: The number of enrolled subjects who have completed the study.

How calculated: For each site, counts subjects who have completed the study, as recorded on the Subject Completion in the InForm application.

UUIDs: PF_SC_COMPLETECTL, PF_SC_STUDY_COMPLETE, PF_SC_STUDY_INCOMPLETE

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database. Percentage is derived for display.

Dropped

Data type: Numeric

Description: The number of enrolled subjects who have dropped out of the study.

How calculated: For each site, counts subjects who have dropped out of the study, as recorded on the Subject Completion form in the InForm application.

UUID: PF_SC_COMPLETECTL

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database. Percentage is derived for display.

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