Click Clinical Safety → Incidents or Privacy & Security → Incidents, then click New Incident.
2
Fill in the dialog
Fill in the Add New Incident dialog.
The Add New Incident dialog. Scroll down for Impacted Product(s), the Clinical Incident and Data Security Incident ticks, and Additional Information.
3
Choose the category and create it
Tick Clinical Incident, Data Security Incident or both, to decide where the incident appears. Both start unticked, whichever log you came from. Then click New Incident to open the Incident Details sheet.
The Incident Details sheet has 5 sections: Incident Information, Clinical Details, Data Security Details, Investigation & Response and Additional Information. To reopen it later, click … on the incident’s row, then Edit.
The top of the Incident Details sheet: Incident Information, with the Clinical Incident and Data Security Incident ticks below it.
Fill in the sections that apply. Root Cause Analysis, Outcomes and Lessons Learned go in Investigation & Response, and assessors read Outcomes and Lessons Learned first, so complete them before closing.Update Status as the incident moves on (see Statuses).