Surveillance

The Surveillance - FAERS sub-tab displays all adverse events reported for all FAERS products included in the user’s ESM, filtered by Active Safety Relevant Observations (SROs) as default. Admin users can then set signal criteria for each drug in their ESM portfolio, enabling them to customize surveillance thresholds and quickly add a Signal, Inquiry, or Request to their ESM. The quick-filters in each column header enable users to filter by or set criteria ranges for each column. Clicking on the three-line menu in the upper right-hand corner of the SRO table enables users to export data, clear filters, and make column display selections.

The Surveillance - FAERS sub-tab allows Admin users for an organization to create their own custom signal criteria for a drug by clicking the edit icon to the left of the drug name column. Any criteria entered in the modal pop-up will be applied to every adverse event for the given drug, and the page will re-load after clicking “Submit” at the bottom of the pop-up. Users can select range fields for EB05, ROR, Cases, etc. Advera can upload an organization’s PSME or CCDS data into their ESM as well. Note that only Admin users will be able to edit the signal detection algorithms. 

Clicking the yellow “Exit” button at the bottom of the pop-up will exit the signal criteria selection box without making any changes to the existing criteria. 

Any adverse events that meet a user’s custom signal criteria for each drug will be listed in the SRO data table with a red “Active” SRO status in the third data column. “Not Active” drug/AE pairs can be selected to view by clicking on the blue “Filter by SRO Status” drop-down menu. These drug/AE pairs do not meet the current custom signal criteria for the given drug. As a default setting for all users, the custom signal criteria for every drug in a user’s ESM will be set as the following (shown also in the image below): EB05 minimum: 2; New Cases (Primary) minimum: 5, and; US Label Status: Not Labeled. 

“New Cases” refers to the number of cases reported in the most recent refresh period for the data source the user is utilizing. For FAERS data, this means the most recent quarter of FAERS data available in Evidex.

To view all previous changes made to the signal criteria for the drug, Admin users may click the blue “Show Edit History” button at the top right-hand side of the pop-up criteria box. This will bring Admin Users to the Audit log for every SRO criterion change across all drugs in the users’ ESM. To view the criteria changes for a single drug, users can click the drop-down menu under the Record column. Users can export data, clear filters, and make column display selections by clicking the three-line menu in the upper right-hand corner of the data table. 

Non-Admin Users may view all change history by clicking on Utilities  Audit Log, and entering in their search criteria. 

The Surveillance ICSR Sub-Tab shows various statistics for Product/Adverse event pairs from the customer supplied ICSR data. Users can choose between DEC Summary View (Drug Event Combination), or Case Review to show a list of underlying cases.

In the “Display Options” dropdown, users can choose between “Display Active SROs in Column” and “Display only Active SROs”. The “Display Active SROs in Column” option shows cases which meet Safety Relevant Observation (SRO) algorithm criteria in the Active SRO Column only. All cases from the entire database are still shown under this option.

The "Display only Active SROs" option shows ONLY cases which meet Safety Relevant Observation (SRO) algorithm criteria chosen by the user.

Users can also create a new Signal, Inquiry or Request for any Product/Event combination by using the “Add to ESM” buttons in the data grid. Clicking these buttons will take you to the corresponding editor page for that record type.

Users have multiple options under the Options/Settings button for exporting the result set via email, as a csv file attached to an ESM record, managing products displayed on this report, and a Bulk Signal Creation utility. Users can also export to csv or pdf, restore default grid sorting, and choose which columns are visible by clicking the three line icon in the upper right corner of the data grid.

To email a csv file, click on the Options/Settings menu and select “Export Results via email”. Provide an email address and a file name before clicking submit. Users will receive a link to download the file in the email.

Users can also attach a file directly to an ESM record. From the Options/Settings menu, click “Export to ESM”. With this utility, users can attach a csv file to an existing ESM record, a new ESM record, or can search for and attach the file to an existing ESM action.

To attach to an existing ESM Record, click the “Attach to Existing ESM Record” radio button. Search for and select the record you want to attach to before clicking Submit.

To attach to a new ESM record, click the “Attach to New ESM Record” radio button and then click the record type you want to attach the file to. This will open a new editor window with the file attached. The “Attach File to ESM” window will dismiss automatically when one of these buttons are clicked.

To attach a csv file to an existing ESM action, first you must search for and choose the action’s associated record (Signal, Inquiry, Request).

After the record has been selected, a list of associated Actions will be shown by clicking the text box below. Click the Action that you want the file attached to before clicking Submit.

Surveillance – EVDAS Sub-Tab

The Surveillance EVDAS module consists of two sub-tabs, eRMR and Line Listings. To access the report, navigate to Evidex Signal Management by clicking the link in the header. Once in the ESM module click the ‘Surveillance’ tab, the ‘EVDAS’ subtab and either the ‘eRMR’ or ‘Line Listings’ sub-sub-tabs.

The data displayed on the eRMR tab represents the products and adverse events provided by the subscriber and includes statistics for ROR, EVPM, EEA, HCP and various outcomes and demographics.

Users can create Signals, Inquiries and Requests for any of the displayed product/event combinations by clicking the corresponding button in the ‘Add to ESM’ column. This will redirect the user to the appropriate admin form to enter the rest of the information for the record.

Users can export the results of the eRMR tab as a csv file by clicking the Options/Settings dropdown and clicking ‘Export Results to ESM’. A modal popup will appear prompting the user to provide a filename and various options for attaching the file to existing or new ESM actions.

Users may filter the datagrid by using the various filters displayed in the grid headers, as is featured throughout the rest of the Evidex site.

Users can easily display all available columns by clicking the ‘Show All Columns’ button at the upper right corner of the datagrid, or individually choose which columns to show or hide by clicking the three-lined button, also found at the upper right corner of the grid.

This grid menu also contains options for exporting to csv, excel or pdf as a file to be saved on their local machine.

The ‘Line Listings’ subtab shows a view of the underlying cases used by Advera to calculate the statistics on the eRMR tab.

In addition to the standard grid header filters, this tab also features an ‘Advanced Case Search’ tab where users can provide more specific criteria to narrow down the cases they are searching for. Click the ‘Advanced Case Search’ button in the upper right corner of the grid, or the Options/Settings dropdown menu to open the advanced filter. After specifying criteria, click the ‘Submit’ button to view the filtered results.

In some cases, the length of the data displayed in datagrid cells on the Line Listings tab exceeds the available size. This can make narratives and paragraphs difficult to read. For this reason, the “Expanded View” button has been added to display all of the data in an HTML table, with all columns visible by default. To return to the datagrid view, click the “Grid View” button.

PSME (Product Specific Monitored Event) and CMQs (Custom MedDRA Queries)

Users can upload their Product Specific Monitored Event (PSME) lists with Evidex’s Custom MedDRA Query (CMQ) builder. This enables users to track whether a given adverse event they are monitoring is on their PSME list. The yes/no values in the PSME (Product Specific Monitored Event) column are driven by whether this preferred term appears in any of a user's CMQs (Custom MedDRA Queries) that are marked with the "Is PSME" flag.

In this example below, PSME is marked as “Yes” for Pulmonary Oedema, because the preferred term Pulmonary Oedema is included in one or more CMQs marked as PSME. PSME is marked as “No” for Pyrexia because it does not.

The CMQ Editor can be accessed by clicking the “Custom MedDRA Queries” option from the “Options/Settings” dropdown menu.

The Surveillance - ICSR page provides a utility to quickly and easily create individual Signals for any number of Product/AE combinations.

Typically, users will first narrow down the list of Product/AE combinations by editing the Custom Signal Algorithm or by using the column filter headers before opening the Bulk Signal Creation utility. This is optional. Users will have the ability to further exclude combinations with the utility.

Next, click the “Bulk Create Signals” option from the “Options/Settings” dropdown menu.

In the Bulk Signal Creation window, confirm your selections using the checkboxes in the left-most column of the table. Once the user is satisfied with the selections, simply click the “Create” button and new Closed Signals will be created for each combination.

Bulk signal creation will create records for each of the selected product/event combinations, including a completed action with the date of the bulk update.

For each signal, the following will be set:

Drug: Product selected below

Topic: Adverse Event selected below

Signal Status: Closed (Pre-Detection)

Signal Closure Date: <todays date>

Source: Clinical Trial Data - DEC Review

Case Review View

The “Case Review” view shows a list of individual cases. From the “View Selection” dropdown, click “Case Review”.

Users can choose between New Cases and All Cases by using the Filter dropdown.

Users can also use the Options/Settings menu from the Case Review page. See the documentation above for instructions on how to use these features.

Users can export to csv or pdf, clear filters and restore default sorting, or choose which columns are visible by clicking the icon with 3 lines in the upper right corner of the datagrid.

Users can access the ICSR Case Profile page by clicking on a Case ID Number from the “Case Review” mode of the “Surveillance - ICSR” page, shown in the previous section.

From the “Surveillance” navigation tab, click the “Surveillance - ICSR” sub-tab. In the “View Selection” dropdown, choose the option for “Case Review”.

In the Case Review datagrid, click a Case ID to view the ICSR Case Profile detail report.

The Case Profile page contains details about the case. The user has several options for exporting, setting Status and Case Series flags, and adding comments.

A case profile can be exported to PDF using the Options menu in the right side of the orange header.

To download a PDF file directly, choose “Export PDF” from the Options Menu.

To email a pdf file, click on the Options menu and select “Export PDF via email”. Provide an email address and a file name before clicking submit. Users will receive a link to download the file in the email.

Users can also attach a file directly to an ESM record. From the Options/Settings menu, click “Export PDF to ESM”. With this utility, users can attach a file to an existing ESM record, a new ESM record, or can search for and attach the file to an existing ESM action.

To attach to an existing ESM Record, click the “Attach to Existing ESM Record” radio button. Search for and select the record you want to attach to before clicking Submit.

To attach to a new ESM record, click the “Attach to New ESM Record” radio button and then click the record type you want to attach the file to. This will open a new editor window with the file attached. The “Attach File to ESM” window will dismiss automatically when one of these buttons are clicked.

To attach a csv file to an existing ESM action, first the user must search for and choose the action’s associated record (Signal, Inquiry, Request).

After the record has been selected, a list of associated Actions will be shown by clicking the text box below. Click the Action that you want the file attached to before clicking Submit.

Users can also add comments by clicking the “add a comment” link (only shows if there are no comments) or the “Add New Comment” button.

Comments can be shared with individuals within your organization, the entire organization, or kept private.

Comments are shared with everyone in the users’ organization by default. To keep your comment private, the user can select the “Private/Not Shared” option in the Sharing section. The flags and status changes are always public regardless of what you choose here, only your comment will be affected by the sharing options.

Options in the Status dropdown can be edited by clicking the “Click to edit these options” link. This will open the options editor in the Admin section of ESM.

Users also have the ability to share a comment with specific people within their organization by choosing the “Shared with specific users” option.

After selecting the users you want to share the comment with, click “Save”.

Once a comment has been submitted, users may edit or delete their comments by using the Edit and Delete links in the comment tables.