Enable EVDAS Data Import for Signal Detection

With the 24R3 release, users can import EudraVigilance Data Analysis System (EVDAS) data into Vault in the form of electronic Reaction Monitoring Reports (eRMRs) and line listings. Users can then perform signal detection in compliance with EMA regulations.

After you have configured this feature, see the following articles for more information:

26R2 Update: EVDAS Data Requests & Automated Processing

With the 26R2 release, Signal facilitates the EVDAS importing process by automating data cleaning and MedDRA coding. This feature also supports routine signal surveillance and ad-hoc signal evaluations by allowing Admins to create Signal Data Requests for a reporting period and users to submit requests for EVDAS data at any time. To configure this feature in your Vault, see Configure EVDAS Data Requests & Automated Processing.

Create Custom Object Layouts

Create custom layouts for the following objects:

  • EVDAS eRMR Data
  • EVDAS eRMR Data Line Listing
  • EVDAS Line Listing

To do this:

  1. Navigate to Admin > Configuration > Objects > [Object] > Layouts.
  2. Do one of the following:
    • Copy the applicable standard layout, set the new custom layout as the default, and delete any other existing custom layouts that are no longer needed.
    • On the Layouts tab, select Create and use the sections below to configure the object layouts.

EVDAS eRMR Data

To configure the EVDAS eRMR Data layout:

  1. Ensure the Details section includes the following fields: 
    • Reporting Period
    • Product Family
    • Active Substance
    • Product-Event Combination
    • PEC Period
    • PT
    • MedDRA Term control field with the Slider (slider icon) icon
    • MedDRA Query
    • SMQ Narrow
    • Alert
    • Changes
    • Listed
    • IME/DME
    • Safety Investigation
    • Detection Date
    • Current Disposition
    • Current Disposition Date
  2. After the Details section, insert the SDR detail form section with the following information: 
    • Section Label: Enter SDR.
    • Section Name: Enter sdr.
  3. Ensure the SDR section includes the following fields: 
    • SDR All
    • SDR Paed
    • SDR Geriatr
  4. After the SDR section, insert the Data detail form section with the following information: 
    • Section Label: Enter Data.
    • Section Name: Enter statistical_data.
    • Section Layout: From the drop-down, select Detail Form - Two Columns.
  5. Ensure the Data section includes the following fields:
    • New EEA
    • New +RC
    • New Spont
    • New Fatal
    • New Serious
    • New Paed
    • New Geriatr
    • New Lit
    • New EVPM
    • Tot EEA
    • Tot +RC
    • Tot Spont
    • Tot Fatal
    • Tot Serious
    • Tot Paed
    • Tot Geriatr
    • Tot Lit
    • Tot EVPM
    • Relative ROR (-) Paed vs Others
    • Relative ROR (-) Geriatr vs Others
    • ROR (-) All
  6. After the Data section, insert the EVDAS eRMR Data Line Listing > EVDAS Line Listing related object section with the following information:
    • Section Label: Enter Line Listings. 
    • Section Name: Enter evdas_line_listings. 
    • Creation Option: Select Create record in pop-up dialog.
  7. In the Line Listings section, edit the default columns to appear as follows:
    • Name
    • Product Family
    • Reporting Period
    • EU Local Number
    • Worldwide Unique Case Identification
    • Case Number
    • Case Version
    • EV Gateway Receipt Date
    • Report Type
    • Literature Reference
    • Parent Child Report
    • Patient Age Group
    • Patient Age Group (as per reporter)
    • Patient Sex
    • Primary Source Qualification
    • Primary Source Country for Reg. Purposes
  8. After the Workflow Timeline section, insert the System detail form section with the following information: 
    • Section Label: Enter System.
    • Section Name: Enter system.
    • Section Layout: From the drop-down, select Detail Form - Two Columns.
  9. Ensure the System section includes the following fields: 
    • EVDAS eRMR Unique Name
    • Created By
    • Created Date
    • Lifecycle State
    • Last Modified By
    • Last Modified Date

EVDAS eRMR Data Line Listing

To configure the EVDAS eRMR Data Line Listing layout, ensure the Details section includes the EVDAS eRMR Data and the EVDAS Line Listing fields.

EVDAS Line Listing

To configure the EVDAS Line Listing layout, ensure the Details section includes the following fields:

  • Reporting Period
  • Product Family
  • EU Local Number
  • Worldwide Unique Case Identification
  • Case Version
  • Report Type
  • EV Gateway Receipt Date
  • Primary Source Qualification
  • Primary Source Country for Reg. Purposes
  • Literature Reference
  • Patient Age Group
  • Patient Age Group (as per reporter)
  • Patient Sex
  • Parent Child Report
  • Reaction List PT
  • Suspect/interacting Drug List
  • Concomitant/Not Administered Drug List
  • ICSR Form (Text)

Update Object Layouts

For the Safety Investigation and Signal Reporting Period object layouts, insert the EVDAS eRMR Data related object section with the following information: 

  • Section Label: Enter EVDAS eRMRs.
  • Section Name: Enter evdas_ermrs.
  • Creation Option: Select Create record in pop-up dialog.

Update the EVDAS eRMR Data Object

To update the EVDAS eRMR Data object, navigate to Admin > Configuration > Objects > EVDAS eRMR Data and update field settings and the list layout.

Update Fields

To update the Active Substance and PT fields to display in default lists and hovercards, navigate to the Fields tab and in the applicable fields, select the Display in default lists and hovercards checkbox.

Update the List Layout

To update the EVDAS eRMR Data list layout:

  1. Navigate to the List Layout tab and select Reorder.
  2. Drag field names so the list layout appears in the following order:
    • EVDAS eRMR Unique Name
    • Active Substance
    • Product Family or Aggregate Reporting Group
    • SMQ Narrow
    • SOC
    • PT
    • MedDRA Term
    • MedDRA Query
    • Alert
    • Changes
    • Listed
    • IME/DME
    • SDR All
    • SDR Geriatr
    • SDR Paed
    • New EEA
    • Tot EEA
    • New EVPM
    • Tot EVPM
    • New Fatal
    • Tot Fatal
    • New Geriatr
    • Tot Geriatr
    • New Paed
    • Tot Paed
    • New +RC
    • Tot +RC
    • New Serious
    • Tot Serious
    • New Spont
    • Tot Spont
    • ROR (-) All
    • Reporting Period
    • Current Disposition
    • Safety Investigation
    • Detection Date
  3. Select Save.

Grant Object Permissions

Ensure your permission sets are updated to grant the appropriate level of access for users to objects and fields according to your organization’s process. Manage object permissions from Admin > Users & Groups > Permission Sets > [Permission Set] > Objects > [Object].

In the applicable permission sets, grant Read, Create, Edit, and Delete permissions for the following objects:

  • EVDAS eRMR Data
  • EVDAS eRMR Data Line Listing
  • EVDAS Line Listing

(26R2) Configure EVDAS Data Requests & Automated Processing

Follow the sections below to configure your Vault for this feature.

Set a Field Default for Signal Data Request & Signal Data Request File Fields

For the Signal Data Request object, configure the following field defaults:

  • Reference Period End Date: Enter reporting_period__vr.end_date__v as the Default Value.
  • Reference Period Start Date: Enter reporting_period__vr.start_date__v  as the Default Value.
  • Request Purpose: Enter If(IsBlank(safety_investigation__v), Picklist.signal_data_request_purpose__v.routine_detection__v, Picklist.signal_data_request_purpose__v.signal_validation__v) as the Default value. 

On the Signal Data Request File object, configure a field default for the Request Data Source field with signal_data_request__vr.request_data_source__v as the Default Value. Select the Default based on Expression checkbox. This configuration ensures the Signal Data Request File object inherits the Signal Data Request value from the parent Signal Data Request.

Update Object Layouts

Copy the standard layout for the following objects and set the new layout as active:

  • Signal Data Request
  • Signal Data Request File

For the following objects, you can copy the standard layout or update the existing layouts: 

  • EVDAS eRMR Data
  • EVDAS Line Listing
  • Safety Investigation
  • Signal Reporting Period

Update the EVDAS eRMR Data Layout

To update the EVDAS eRMR Data object layout: 

  1. Add the following fields to the Details section: 
    • MedDRA Term control field with the Slider icon; remove the MedDRA Term field 
    • Data Request
    • Data Request File
    • Reference Period Start Date
    • Reference Period End Date
  2. Add the following fields to the Data section:
    • New EVPM Link
    • Tot EVPM Link
  3. In the Line Listings section, edit the default columns to add the following fields:
    • Reaction List PT (Extracted)
    • Reaction List PT
    • Suspect/Interacting Drugs (Extracted)
    • Suspect/interacting Drug List
    • Concomitant/Not Admin Drugs (Extracted)
    • Concomitant/Not Administered Drug List
    • ICSR Form (Text)

Update the EVDAS Line Listing Layout

To update the EVDAS Line Listing object layout, add the following fields to the Details section: 

  • Safety Investigation
  • Data Request 
  • Data Request File
  • Suspect/Interacting Drugs (Extracted)
  • Suspect/Interacting Drug List
  • Concomitant/Not Admin Drugs (Extracted)
  • Concomitant/Not Administered Drug List
  • Reaction List PT (Extracted)
  • Reaction List PT
  • Aggregate Reporting Group

Update the Safety Investigation Layout

To update the Safety Investigation object layout, insert the Signal Data Request related object section with the following information: 

  • Section Label: Enter Data Requests
  • Creation Option: Select Create record in pop-up dialog

Update the Signal Reporting Period Layout

To update the Signal Reporting Period object layout, insert the Signal Data Request related object section with the following information: 

  • Section Label: Enter Data Requests
  • Creation Option: Select Create record in pop-up dialog

Configure Signal Data Request Actions

To configure the Import EVDAS Data action and the Link EVDAS eRMRs and Line Listings action, assign the actions to the Signal Data Request object. Then, add the actions as a user action to the applicable states of the Signal Data Request object lifecycle: 

  • Add the Import EVDAS Data action to the In Progress, Error, and Imported with Warning states with the following information:
    • Condition Type: Select All conditions are met
      • If: Select Request Data Source > equals > EMA - EVDAS
      • Allow the following actions: Select Import EVDAS Data
        • Action Label: Enter Import EVDAS Data
  • Add the Link EVDAS eRMRs and Line Listings action to the Imported state and the Linking Error state with the following information:
    • Condition Type: Select All conditions are met
      • If: Select Request Data Source > equals > EMA - EVDAS
      • Allow the following actions: Select Link EVDAS eRMRs and Line Listings
        • Action Label: Enter Link EVDAS eRMRs and Line Listings

Configure the Signal Data Request Object Lifecycle

Completing a Signal Data Request requires changing the lifecycle state during the appropriate steps. Using the following table, configure state change user actions for the applicable Signal Data Request object lifecycle states:

Lifecycle State User Action
New
  • Condition Type: Select Always
  • Allow the following actions: Select Change State to > Open
    • Action Label: Enter Change State to Open
Open
  • Condition Type: Select Always
  • Allow the following actions: Select Change State to > In Progress
    • Action Label: Enter Change State to In Progress
Linking Success
  • Condition Type: Select Always
  • Allow the following actions: Select Change State to > Complete
    • Action Label: Enter Change State to Complete
Error
  • Condition Type: Select Always
  • Allow the following actions: Select Change State to > In Progress
    • Action Label: Enter Change State to In Progress
Imported with Warning
  • Condition Type: Select Always
  • Allow the following actions: Select Change State to > In Progress
    • Action Label: Enter Change State to In Progress
  • Allow the following actions: Select Change State to > Complete
    • Action Label: Enter Change State to Complete

Configure Notifications

Vault does not provide standard notification templates for Signal Data Requests. You can configure email and notification messages for the Signal Data Request object to notify the appropriate users after a record state change or when an action completes. 

After configuring notification templates, add a Send a Notification entry action for the applicable Signal Data Request object lifecycle states or configure the Signal Data Request workflow according to your business needs.

Optional: Configure the Data Requests Tab

Optionally, you can configure a tab to view all Signal Data Requests in a single list. Create a custom tab with the following information: 

  • Label: Enter Data Requests
  • Tab Type: Select Object
  • Object: Select Signal Data Requests

After configuring the tab, you can add it to an existing tab collection.

Grant Permissions

Ensure your permission sets are updated to grant the appropriate level of access for Admins and users to objects, fields, and tabs according to your organization’s process. Manage permissions from Admin > Users & Groups > Permission Sets > [Permission Set].

Object Permissions

In the applicable permission sets, select the Objects tab and use the following table to grant permissions:

Permission Set Object Object Permissions Field Permissions Object Action/Control Permissions
[Applicable Admin Permission Set] Signal Data Request
  • Read
  • Create
  • Edit
 N/A
  • Import EVDAS Data: Execute
  • Link EVDAS eRMRs and Line Listings: Execute
Signal Data Request File
  • Read
  • Create
  • Edit
  • Delete
 N/A N/A
EVDAS eRMR Data N/A
  • New EVPM Link: Read
  • Tot EVPM Link: Read
  • Reference Period End Date: Edit
  • Reference Period Start Date: Edit
 MedDRA Term: View
EVDAS Line Listing N/A
  • Concomitant/Not Admin Drugs (Extracted): Read
  • Concomitant/Not Administered Drug List: Read
  • Reaction List PT: Read
  • Reaction List PT (Extracted): Read
  • Suspect/Interacting Drugs (Extracted): Read
  • Suspect/interacting Drug List: Read
  • ICSR: Read
 N/A
[Applicable User Permission Set] Signal Data Request
  • Read
  • Create
  • Edit
 N/A N/A
EVDAS eRMR Data N/A
  • New EVPM Link: Read
  • Tot EVPM Link: Read
  • Reference Period End Date: Read
  • Reference Period Start Date: Read
 N/A
EVDAS Line Listing N/A
  • Concomitant/Not Admin Drugs (Extracted): Read
  • Concomitant/Not Administered Drug List: Read
  • Reaction List PT: Read
  • Reaction List PT (Extracted): Read
  • Suspect/Interacting Drugs (Extracted): Read
  • Suspect/interacting Drug List: Read
  • ICSR: Read
  • Safety Investigation: Read
  • Aggregate Reporting Group: Read
 N/A

Tab Permissions

In the applicable permission sets, select the Tabs tab and grant View permission for the Data Requests tab.