Auto-Dismissal of Signals (Optional Module)
From the Drug/AE Analysis page, user can select from the following list of internal fields to assist with signal triage of safety observations:
a. Listedness (Internal) – determination of whether the drug/event pair is listed in the product’s labeling information.
b. Underlying Disease Relatedness (Internal) – determination of whether the drug/event pair is caused by one or more underlying condition the product is indicated to treat.
d. Risk Management Plan Inclusion (Internal) -whether the product/event pair is listed in the product’s Risk Management Plan.
f. Other Health Authority Recommendation (Internal) – determination whether a health authority outside of the EU has recommended that the drug/event pair should be added to the product label information.
g. Martindale -whether the drug/event pair is known or expected based on the drug reference guides available from Martindale.
User can edit these auto-dismissal fields by clicking the “Edit Auto-Dismissal Prerequisites” button on the top right-hand corner of the Overview page. The user can select the field they wish to edit and choose the desired selection from the dropdown list for that field and click “Save Changes” to save the selections made. User can also click “Cancel” if they no longer wish to make any changes to the Auto-Dismissal fields prior to saving.
Once an Auto-Dismissal field is selected, it will be displayed on all applicable pages including:
1. The Drug/AE Analysis page.
2. The Source Comparison page for that product.
3. Surveillance Pages (ICSR, EVDAS)
The Auto-Dismissal field is a calculated field which displays yes or no based on each client’s business rules as configured by Evidex as required during the implementation of Auto-Dismissal functionality.