Evidex Signal Management - Adding Signals

There are four ways to enter a signal into Evidex Signal Management:

Users can manually enter a signal from within Evidex Data & Analytics from the Drug page FAERS – Adverse Events tab:
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Or from any Drug/AE Analysis page:
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Clicking on the red “Signal” button from either page will bring users to the “Add Signal” sub-tab within Evidex Signal Management. There are required and optional fields when adding a signal. Note that many of these fields and the options associated with them are configurable under the Utilities tab. Click here to read more about configuration options. 

Users must add a Signal ID. The product and MedDRA PT are already filled in based on the drug/AE pair the user is working on. Users may also add additional PTs or SMQs create a custom list. To add an adverse event, start typing into a MedDRA PT or SMQ text box, then click on the desired term(s). 

The “Date Detected” field is auto-populated based on the date the user is adding the Signal. To change the “Date Detected” users can click the round “x” to clear the displayed date, click the up/down arrows to move the date numbers higher or lower, or click the shaded black arrow to open a calendar menu to select a new date from. This enables users to log previously detected signals into Evidex Signal Management. Users can also click on the date and use their keyboard to enter in numbers for a different date.
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To set the “Status” or “Signal Management Phase,” click on either text box field and select the desired Status or Phase. Signals are automatically set to display “New” in the “Status” field. If a user is logging a Closed Signal, or completing the actions needed to close the Signal at the time of entering the Signal, they can populate the “Signal Closure Date” field. 

Users must select a “Source or Trigger of Signal” when entering a new Signal. Clicking on the “+” icon next to a Source will open a drop-down menu of specific Sources to choose from. Clicking the box adjacent to a Source will add it to the given Signal. Note that the options showing under this section are all customizable. Click here to read more. 

More information about the Source can be entered by the user in the Source Detail text box.

Users can click on one or more names from their organization in the "Responsible Persons" section to assign the Signal to a user. The person assigned to a new Signal will receive an email notification from esm@adverahealth.com.
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Users can make further optional selections within the Validation, Prioritization, Evaluation, and Assessment sections. Clicking the drop-down menus from “Signal Validation Status”, “Signal Prioritization”, “Risk Priority”, or “Signal Disposition” and clicking on the desired item as the user moves through the phases of signal management. Optional text can be typed into the text boxes for “Justification of Risk Priority”, “Method of Signal Evaluation”, or “Reason for Evaluation & Summary of Key Data” or "Analysis Comments" text boxes. Users can also add text to the “Comments” box at the bottom of the Signal screen. 

Users can choose to link existing Signals or Inquiries with similar events/topics to the new Signal by searching for key words within the “Associated Signal/Inquiry IDs” box.  Clicking “add” next to the desired records will link them to the new Signal. 

Users may enter in additional comments on the Signal within the Comments box. Users may link to one or more documents by selecting “Choose File” to upload from their local files or copying and pasting a link to a URL document. 

Clicking the blue “Save” button at the bottom right will save and enter the Signal into Evidex Signal Management. Users can click “Save and Continue Editing” to save the Signal and continue editing it.   

After clicking “Save,” users will be brought to the Signal Detail Report, showing a summary of the logged Signal. To download a PDF of the Signal Detail Report, click the red “View PDF” button at the top right. To further edit the signal, click the blue “Edit” button. To view the Audit Log for the Signal, click the adjacent blue “Show Edit History” button. Clicking on the link for any Associated Signal/Inquiry/Request will take open the given linked Report Detail. Clicking on the text for any Supporting Documents will open the linked documents.

To create a Future Action related to the Signal, click the “Add New Planned Action” button. To log a Completed Action, click the blue “Add Completed Action” button.