Sections in This Article
Prerequisites
An administrator must have:
- Enabled EVDAS Signal Detection.
- Created an EVDAS eRMR Signal Report with a Reporting Period Start and End Date.
You must have added Substances to the Signal Product Profile since EVDAS Signal detection displays data linked to the Substance(s) from the Signal Product Profile.
To use Signal detection for EVDAS data, make sure you have the following materials:
- The eRMR provided by EVDAS. The eRMR, or Electronic Reaction Monitoring Report, is a summary report that EVDAS provides at the PT level.
- The mapping file provided by Veeva Support.
- This file is used to map fields using Vault Loader.
About EVDAS Signal Detection
EVDAS Signal Detection uses the Substance(s) in the associated Signal Product Profile, unlike for the FAERS and PV data sources which use the Product(s).
The steps for EVDAS Signal detection are as follows:
- An administrator must prepare the eRMR.
- Load the eRMR into Vault Signal using Vault Loader.
- Use the EVDAS eRMR panel.
From this screen, you can apply filters to the EVDAS data and export your filtered selection.
To learn more about EVDAS, see Signal Data Sources: About the EVDAS Data Source.
To learn more about Signal Detection for other data sources, see Use Signal Detection.
Load the eRMR into Vault Signal
Use the following criteria to make sure the file is valid for loading:
- The eRMR format is in
.CSV
. - The file must contain valid MedDRA PTs.
- The eRMR must contain the standard fields. Do not add or remove any columns or change the column order when exporting the
.CSV
file from EVDAS.
To load an eRMR into Vault Signal, perform the following steps:
- Go to Business Admin (Quick Access) > Loader.
- Complete the following information:
- CSV File: Select the eRMR
.CSV
file. - Object Type: Signal EVDAS eRMR (
signal_evdas_ermr__v
) - Action Type: Create
- Select the dropdown beside Map Fields > Load Saved Mapping > From your folder, select the mapping file provided to you.
If you do not have this mapping file, contact Veeva Support or select Map Fields. The Map Fields option automatically maps the columns in the.CSV
file to fields in Vault Signal.
- CSV File: Select the eRMR
- Select Start Load.
For more information on field mapping and how to use Vault Loader, see Vault Loader: Create, Update & Delete Object Records.
Results
The system starts a job to load the eRMR into Vault Signal. Once complete, the sends you a notification detailing whether the job was successful or not.
Note that each success or failure represents one row from the report. If there are failures, you can select them from the notification to access the failure log and error descriptions.
The successfully loaded reports are available in the Admin area under the Signal EVDAS eRMR object.
Use the EVDAS eRMR Panel
Once you have successfully loaded the eRMR into Vault Signal, you can access it from the Signal Detection Dashboard. Go to Signal > Signal Product Profiles > Open Detection from a Signal Product Profile.
Next, navigate to the EVDAS eRMR panel beside the Detection Summary to access the loaded data.
All the EVDAS data for the Substances linked to this Signal Product Profile is displayed on this dashboard.
From this dashboard, you can add and reorder the displayed columns in the Product-Event Combinations grid, excluding Active Substance, Signal, Tracking, and Lifecycle State, which are fixed. This organization of columns for EVDAS eRMR will be saved across all Signal Product Profiles.
You can search for Product-Events, Preferred Terms (PTs), and System Organ Class (SOC) terms using the search bar, or you can filter for Product-Events by selecting the filter in each column . Only columns with numeric values can be filtered (for example, Start and End Date, EVPM scores, and EEA scores). For more information on filtering and searching in the grid, see Filter and Search in the Product-Event Combination Grid.
Finally, you can track a Product-Event from this page. Once you track a Product-Event, the Product-Event appears under the Signal > Product-Events tab.
Your Admin can export the EVDAS data in .CSV
and .XLS
format.
The following table describes the default columns in the EVDAS Product-Event Combinations grid:
Column | Description |
---|---|
Active Substance | The Substance in the EVDAS eRMR. Displayed Substances on the EVDAS eRMR record match a Substance on the Signal Product Profile. This column is read only. |
Signal | A Product-Event pair denoted by the Preferred Term (PT). This column is read only. |
Tracking | Allows users to track a Product-Event pair as a Signal record. Tracking a Signal updates the Detection Summary panel and creates an entry in the Product-Events section of Vault. The tracked Signal is also linked in the EVDAS eRMR section of the Product-Event. If you do not see this section, your Admin must add it to the Product-Events page layout. This column is read only. |
Lifecycle State | The current lifecycle state of the Signal record. This column is read only. |
Start Date | The start date for the reporting period. |
End Date | The end date for the reporting period. |
IME/DME | This column indicates whether the MedDRA PT corresponds to an Important Medical Event (IME) or a Designated Medical Event (DME). |
New EVMP | The number of cases for the concerned Drug-Event-combination (DEC) received in the EudraVigilance Post-Authorisation Module (EVPM) during the reporting period. |
Total EVMP | The total number of cases for the concerned DEC received in the EVPM, including the reporting period. |
New EEA | The number of cases for the concerned DEC originating from the European Economic Area (EEA) and received in the EVPM during the reporting period. |
Total EEA | The total number of cases for the concerned DEC originating from the EEA and received in the EVPM, including the reporting period. |
To learn more about the column options in the EVDAS eRMR, see the EudraVigilance User Manual.