Only Admin users within Evidex Signal Management (ESM) can add new or edit existing products within the system. To add a new Drug/Product to ESM, click on the Utilities tab:
Next, scroll down and click the “Add/Edit Drugs/Products” link at the bottom left-hand side of the page:
Here, Admin users can view all current drugs/products, edit the product names, or delete products.
To add a new Product name, click the blue “Add Product” button.
This will open the “Add Product” screen. Users must type in an “ESM Product Name” -- this can be the active ingredient, clinical trial name, or trade name – however the user would like the product to be represented in ESM. Users may then search for an "Evidex Drug" name to associate with the ESM Product Name. Note: This step is necessary if the user would like to link their product with Advera's FAERS data to perform signal detection on. Otherwise, it is not required.
For users with ICSR access, use the “MCN Products (optional):” field to map the organization’s ICSR data from Argus, ArisG, Veeva, etc. to their ESM products. This will ensure the ICSR data will display in the Surveillance – ICSR tab.
Clicking “Submit” will save the Product to the user’s ESM. Clicking “Cancel” will exit the screen without saving.
All other users within the Admin user's organization must refresh their browser to view the changes in their ESM account.
Editing or Deleting an Existing Product
To edit or delete a product, click the Product Name. Users can edit the ESM Product Name, and choose whether to associate it with a Drug Page in Evidex (optional). This allows users to track products that may not have a drug page within Evidex.
Clicking “Delete” for a Product name option that is associated with other records within the user’s Evidex Signal Management will prompt the following warning message. Users will be required to reassign the associated records or remove the Product Name from those records before being allowed to delete the given Product Name. Clicking “Cancel” will exit the screen without deleting.
Clicking “Delete” for a Product Name that is not associated with other records within the user’s Evidex Signal Management will prompt the following message. Then the user can safety Proceed with Delete. Clicking “Cancel” will exit the screen safety without deleting the Product Name.
