Subject Events report

In this report, you view all actions that have occurred to each subject, all in a single location.

The report also includes subjects' randomization numbers and the numbers of the kits that were dispensed to them (this information isn't unblinding because this data is available to blinded users in the user interface).

This report is a good way to see what's happening with each subject, including their current visit. Note that it will include events and visits that were dynamically added to a subject's schedule. Filtering makes this report even more useful, letting you find exactly what you need. You have several options for filtering:

• Like any other report, you can filter the type of data that you want included in the report.

  For example, you can include only code breaks or screen failures that have occurred in a study.

• You can also run this report as a CSV file and then use column-level filters to see only the data that you care about.

This report includes a full history of a subject, so expect lots of details, including multiple lines for each subject. For every event, you'll see one line for every time something happens, such as when a visit is started or completed and when a visit date is changed.

This report can also be customized by adding more data records in it. For more details, see Add custom fields to a report.

Note:

Hidden questions are included in the report only if the user generating the report has the permissions to view or edit hidden data.

Modes

Available in all 3 modes: Testing, Training, and Production

Permission required to run the report

Any user who's assigned the Run the Subject Events Report permission can generate this report.

Filters

Filter	Description
Study Version	Choose a study version to include only actions that occurred in that study version, or choose All to include events that occurred in all study versions.
Location	Choose a site or depot to include only the actions that occurred at the location, or leave the filter blank to include actions for all locations.
Current Subject Number	Choose a subject to include only the actions that occurred to the subject, or leave the filter blank to include actions for all subjects. Note: If a subject is removed from a study and its subject number is subsequently reused, then there will be two entries for that subject number within the report.
Event Type	Choose the event type, such as Visit Started, to include only actions in those events, or leave the filter blank to include actions for all event types.
File Type	Choose the output type for the report: CSV HTML PDF Note: We recommend choosing CSV, so that you can narrow your view of the data.

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.
Location	The site or depot you previously selected to be included in the report.
Report Generated By	User name of the user who generated this report.
Created Date	UTC time and date of the current generated report.
Event Type	The event type you previously selected to be included in the report.
Subject Number	The number of the subject you previously selected to be included in the report.

Indicates the unscheduled visit's number or branch visit instance

Fields for a subject's events	Description
Study Version	Study design version for the visit.
Site	A site's name.
Country	A site's country.
Subject ID	A subject's ID. Included as part of the report for integrated data purposes.
Current Subject Number	Indicates a subject's current subject number at a site.
Previous Subject Number	Indicates a subject's previous subject number at a site. If no subject number update was performed, this column indicates N/A.
Screening Number	This matches the value in the Current Subject Number column unless the Screening Number is changed.
Event Type	Indicates the data collection status of the event, such as: New Subject Visit Started Visit Completed Screened Screen Failed Randomized Signed (Visit Level Signature or Subject Level Signature) Unsigned Verified Unverified Code Break Locked Unlocked Visit Date Entered Visit Date Cleared Subject Number Changed Undo Add Subject
Visit/Event Title	Name of visit or branch visit from Study Design. May be N/A if the event is a subject action such as screen failure, locking, randomization, code break, and withdrawal.
Visit/Event Instance	Indicates the unscheduled visit number or the branch visit instance for a subject.
Visit/Event Status	Indicates whether a visit's status is: NOT_STARTED: A placeholder status for in-between visits. NEW: The visit has not been started. INPROGRESS: Any field for a visit is complete without any validation errors, or data has been partially entered for that visit. COMPLETE: All required fields for a visit are complete with no validation errors. COMPLETE_ERR: "Complete with errors," all required fields for a visit are complete, or contains a validation error. INCOMPLETE: If any of the fields are marked as Null for a completed visit. INCOMPLETE_ERR: "Incomplete with errors," a field for a completed visit is marked as Null, or one of the fields contains a validation error. SKIPPED: The visit has been marked as Skipped. UNDO_SKIP: When the visit has been marked as Undo Skip. N/A: No visit data is applicable.
Visit/Event Date	Date of the event entered by the user.
Date	UTC date and time of a subject's event specified in the Event Type column.
Dispensed Date	Reflects the date when a kit was replaced.
Kit Description	Indicates a short description of each kit dispensed to a subject. Data for this column can be either visible or blinded based on role and study design.
User Comment	Required comment in reason for change if ‘Other’ is selected.
Reason	Indicates reason for selected actions. For example, Manual Screen Fail, Code Break, or Withdraw. Note: This field will not populate for replacements kits.
Randomization Number	Indicates a subject's randomization number if assigned in the event.
Replaced Kit / Lot Number	Indicates the kit (serialized inventory) or lot (non-serialized inventory) number that have been replaced.
Dispensation Kit / Lot Number	Numbers of kits (serialized dispensation), or a grouped quantity of kits (non-serialized dispensation), dispensed to a subject during a visit. The number of locally sourced kits displays if applicable.
Transfer Original Site	Site a subject is transferred from. Note: After updating any subject data, allow the system a 15-minute buffer time to load existing commands before making any other changes to subject data or related reports.
Transfer New Site	Site a subject is transferred to. Note: Before transferring a subject, clear out all data inputs that connect to the subject's former site (for example, subject data or event-related reports). If you make edits after transferring the subject to a new site, the edits will show in the new site.
Transfer New Subject Number	The number of the subject after the transfer.
User Name	User name of the user responsible for the transaction.
Undo Add Subject	Indicates the subject has been removed from the study.