To add and close out a Signal without formally adding it to the signal management workflow, either click the red “Signal” button from the Surveillance – FAERS tab:
Or users can choose to manually enter an item by clicking on the Signals tab, and selecting “Add Signal”:
Enter in required details, including the Signal ID. Next, scroll down to the “Status” field, and click the drop-down menu to make a selection. Note that the options displayed here are configurable within the Utilities tab under “Data Functions” for each organization. Click here to read more about editing Data Functions.
Next, choose the Signal Management Phase. Selecting “Adjudicated: Not Added to Signal Management” will log the item within ESM for regulatory purposes without adding the item to the ESM workflow for Open or Ongoing Signals. The Signal Management Phase options can be added or managed within the Utilities Tab under “Data Functions”.
To read more on completing a Signal form, click here.
To view all items that were not added to Signal Management, go to the Signals tab, and filter the “Signal Management Phase” column by “Adjudicated: Not Added to Signal Management”.
Users can bulk edit and close out several items at once to clear them out of their signal management workflow and mark them as “Closed – Pre-Detection” by using the Bulk Signal Creation tool on the Surveillance - ICSR sub-tab.
See the “Bulk Signal Creation” section of the Surveillance documentation for more information.