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:

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
    • MedDRA Term
    • PT
    • 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. Optional: 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
    • Product Family
    • MedDRA Term
    • MedDRA Query
    • Active Substance
    • PT
    • 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