Signal Detection Plan Reviews can be used to automatically schedule and create ongoing reviews on a regular basis using templates. Signal Detection Plan Reviews in Evidex Signal Management (ESM) allow PV professionals to easily conduct ongoing monitoring of signals according to their Signal Detection Plan. PV teams can integrate their Signal Detection Plan into Evidex and receive a reminder when they need to review data on a signal that requires automated monitoring. Multiple signals which require reviews from various data sets (ICSR, EVDAS, FAERS, Vigibase, VAERS, Literature, etc.) and different periodicities (Daily, Monthly, Quarterly, etc.) can all be seamlessly tracked within ESM. When the PV professional performs this review, they can easily attach case documentation or line listings from all of integrated data sets within ESM. They can also add comments on any finding/conclusions made during that review.
To begin, log in with a user account with the appropriate access permissions, click the “Evidex Signal Management” tab from the home screen, then select the ESM Reviews Tab, and the Signal Detection Reviews subtab. This will bring you to the Signal Detection Plan Reviews Outstanding Summary page, which shows the most current or upcoming review for each template.
This page is likely blank if no templates have been created yet. If there are Reviews Outstanding here, users can choose to View Edit History, or Bulk Sign Off on several Reviews at once. You can also use the column header filters to filter the data table by any of the data columns, and export data or hide columns by clicking the menu icon in the upper right corner of the data table. The first step is to click “+Add Signal Detection Plan”.
From the Add Signal Detection Plan Template page, the details of the reviews can be specified. This is not the same as performing a review. Actual reviews will be initiated by a scheduled task on the dates specified in this template.
Type in the name of the Signal Detection Plan Review Title. Next, the schedule of new reviews can be specified using the 'To', 'From' and 'Frequency' fields.
For example, a user could click on the “Frequency” drop-down and select “Weekly”. To create a recurring Review, under the “Recurring” drop-down, select “Yes”. Then specify the date range 4/12/2021 - 4/27/2021 using the “From” and “To” calendar fields, and upon saving the template, a review will be immediately created, and then a second review would be created on 4/19/21 and a third on 4/26/21. After the 'To' date has passed, new reviews will no longer be automatically created.
Users can enter a “Due Date (after period end date)” which will populate the Due Date for the Reviews. For our example, selecting “3” days will trigger each weekly Review to be due 3 days after each weekly due date for the time period specified.
Users can select one or more “Responsible Persons” from their organization. These users will receive email notifications regarding the Review, and reminder emails when Due Dates are approaching or overdue.
Email notifications will be sent to Responsible Persons via esm@adverahealth.com on the Frequency they have selected in the template:
Daily: On Each Due Date
Weekly: 2 Days Before Each Due Date, and Each Day After
Every 2 Weeks: 2 Days Before Due Date, and Each Day After
Monthly, Quarterly, Annually: 1 Week Before Due Date, 2 Days Before Due Date, and Every Day After
Selecting “Product Names” from the drop-down menu allows users to list the product(s) to be included in the Review. Type in a “Topic” to list the topic of the Review. Users can also search for and select MedDRA Preferred Terms or SMQs, list specific Trials that should be reviewed, different Data Sources, and whether to Send Emails associated with this Review.
Additional optional fields include typing in a Trial name associated with the Review, selecting a Data Source for the Reviews to be completed on, and choosing whether Responsible Persons should receive email notifications from esm@adverahealth.com regarding due dates for the Reviews.
Lastly, after completing all Required Fields, users can also add a hyperlink or choose a local file to upload Supporting Documents for the Review. This will attach the document to the Review Profile for the Template. If you are attaching a local file from your computer, ensure that you click the blue ‘Upload’ button after selecting the file to attach it to the Template.
Clicking the 'Save Template (Populate Upcoming Reviews)’ after filling in all required fields will then bring you to the 'Review Profile’ page. Users with appropriate access levels may edit or delete the template using the 'Edit Template' and 'Delete Template' buttons in the upper right corner of the screen. Clicking ‘Show Edit History’ will bring you to the Audit Log for the Review Template.
This Review Profile page provides a list of current and upcoming reviews as well as a list of completed reviews for a given Template. Only reviews where the start date has elapsed will be able to be conducted.
If a user is assigned to a review, they can conduct the review by clicking the date range for the Review they wish to work on under the first column titled ‘Period Covered’. This will bring them to the 'Conduct SDP Review' page.
On the conduct review page, an assignee will be able to add any necessary comments/justifications, file attachments, or web links using the 'Add Comment' and 'Add / Edit Documents' buttons.
Using the “Bulk Attach Documents” button will enable you to bulk attach the document to all reviews of the same frequency. You can select and deselect different Review Titles from the modal pop-up to choose which Reviews to attach the document(s) to.
Once the assignee is satisfied with the review, they can click the 'Sign Off Now' link in the 'Responsible Persons' section. A modal window will appear that will prompt the user for their login credentials. Click the 'Submit' button to complete the review. Users of the Evidex 'single sign-on' feature will not be prompted for credentials.
A list of all created templates can be viewed using the ‘Signal Detection Plan’ link in the fourth row of the tab navigator.