Exceptions Workflow
The system provides a standard, built-in workflow for handling data entry values that may be considered protocol exceptions. These exceptional values flow through the following steps:
- Flagged at the time of entry as being an exception
- Analyzed and determined to be not clinically significant (NCS), clinically significant (CS), or a protocol deviation (PD)
- Associated with a corresponding subject log entry
- Certified by the Principal Investigator or Site User
Exception Flags
As data is entered at the procedure level, the values are analyzed against pre-configured formulas to determine if they are exceptions. Values that match these formulas will be flagged as exceptions and a visual indicator will be displayed next to each item. Common triggers for exceptional values include values outside of normal ranges or percentage change from a baseline value. Once a CRF has been flagged as an exception the status of not clinically significant (NCS), clinically significant (CS), or a protocol deviation (PD) can be analyzed or it can be done on the Exceptions tab.
Exceptions Screen
Once a value has been flagged as an exception, the rest of the workflow is completed on the Exceptions screen. This screen is accessed by clicking on the "Exceptions" tab on the subject screen. An indicator will be displayed with the count of pending items that need to be addressed for the subject.
Log Associations
Once a determination has been made on the type of exception, an item can be linked to an entry in the appropriate log. For example, CS items can be associated with an Adverse Event or Medical History record. Each item can be linked to an existing log entry or a new entry can be created directly from the Exceptions screen.
After an item has been linked with a log entry, that association will also be displayed on the corresponding log screen. If a log entry has been linked to another item in the system, there will be an association indicator displayed and hovering over the indicator will display the details for each associated item.
The logs available for CS, NCS, and PD items are configurable and may differ from protocol-to-protocol. Please contact your Monitor if you have questions on the specific use of the logs for your particular protocol.
Exception Certification
After an item has been associated with the appropriate log entry it can be certified as being complete. Certifying an item is done by clicking on the "Certify" button once all values are confirmed to be correct.
Once an item has been certified it will be moved from the "Pending" list to the "Certified" list.
Note: The timestamp in the When column in the audit trail of Certify action, accessible by clicking on the clock icon, is in the timezone set up on the viewer's device and will be updated accordingly if the viewer changes timezone setting.
The flagged exception on the visit data entry screen will turn green signaling it has been certified.
