Not Done Workflow
If a Procedure, Measurement, or Visit is not performed it should be marked as Not Done within Vessel. The Not Done Workflow allows a site user to associate a documented exception or protocol deviation as the reason the Procedure, Measurement, or Visit was not performed.
Depending on data collection need of the study, the Not Done workflow can disabled on the Procedure and Measurement level. Please contact your study monitor, data manager or send a support request to crsupport@flatiron.com to confirm if the Not Done workflow is enabled for your study.
Reason Not Performed/Not Done
When marking a Procedure, Measurement, or Visit as Not Done, the system will prompt for the reason it was not performed and allow for selecting an existing reason in a dropdown list, or add New Entry to be associated as the reason.
If adding a new reason by clicking on the +New Entry button, the system will prompt for a series of protocol specific questions. At a minimum, these usually include:
- Date of Exception/Event
- Exception/Event Type
- Exception/Event Description
Once the reason is entered, it will be available for selection in the dropdown menu:
Select the appropriate reason and click Select button to save your selection
Measurement Not Done
If a Measurement within a Procedure was not complete it should be marked as Not Done:
Note: The fields will be removed from the Missing Field Count only after the user chooses a reason not done and clicks the Select button.
Procedure Not Done
If a Procedure within a Visit was not complete, it should be marked as Not Performed:
Note:
- A Procedure marked as Not Performed can still be submitted for Monitor review
- In the audit trail of Procedure Performance, accessible by clicking on the clock icon next to the question
Was the procedure performed?, the timezones of timestamps are as follows:
Whencolumn: timezone set up on the viewer's device and will be updated accordingly if the viewer changes their timezone setting.
Visit Not Done
If an entire Visit is missed, it should be marked as Not Performed:
Visits that are missed are called out in red on the Subjects Visit page:
- audit trail of not-done workflow on form-level: When column is in viewer's timezone, regardless of roles
- audit trail of not-done workflow on measurement-level:
- audit trail of not-done workflow on visit-level: When column is in viewer's timezone, regardless of roles