GETTING STARTED IN EUDRAVIGILANCE STEP-BY-STEP GUIDE
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Logging into EudraVigilance The address for the EudraVigilance production system is: http://eudravigilance.emea.eu.int/veterinary/ The address for the Test system is: https://erstest.emea.eu.int/vet/v2 To log into the system, you must click on either “Test” or “Production”, next to “Registered users” on the top right hand side of the screen. The system will ask you for a user name and a password, which you should have received when you registered with Eudravigilance:
Once you log in, you arrive to the following screen:
From this screen, you have access to the following menus: EV Services: EVWEB: is a tool designed for the transmission of ADRs and acknowledgement messages to EudraVigilance through the Internet.
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EV Post: is a Message Posting facility, available only to webtrader transmission mode users. It allows users to send XML messages generated by their in-house database directly to the EudraVigilance Database Management System (DBMS), without using EVWEB. A browse facility will allow you to select, from your PC, the files that you wish to send to the EudraVigilance DBMS.
To send a file click on “EV Post”, and you will arrive to the screen shown above. Press “Browse”, this will take you to your local file system, where you can select the file you wish to send. Once you have chosen this file by clicking on it, its path will be shown on the field next to “Browse”. Then just press “Send”. EV Registered partners: Here you can find a list of the organisations (both Pharmaceutical Companies & Regulators) currently registered in EudraVigilance. User Support – Helpdesk: You can contact the EudraVigilance helpdesk via e-mail from this menu. Now, click on EVWEB in order to continue the tour.
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The EVWEB Screen
EVWEB has a “Display settings” menu at the top left hand side of the screen; you can use this menu to change the fonts of the application. You can choose, from a variety of settings, the most suitable one for your requirements.
The EVWEB screen also contains a set of eight buttons that are always present in any section of the application: “Create and Send ADRs”, “Create and Send Acks”, “WEB Trader”, “ADRs”, “Create and Send Product Reports”, “Medicinal Products”, “VedDRA”, and “Human VedDRA”. Each of these buttons takes you to a different part of the application; further details for each section are given in the next sections.
Below those, there is another row of buttons, the “Dynamic button set”; this set of buttons changes depending on what section of the application you are in. If you rest your mouse pointer on any of the above mentioned buttons (without clicking!), the “arrow” will change into a “hand”, and an explanation on the function of the button will appear on the grey space next to “Display settings”, above the first button set.
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1 – Create & send ADRs
This button gives access to the part of the application dedicated to the creation and modification (follow up) of ADRs, which are sent as “Messages” to the database. There is a tutorial explaining how to create and send ADR messages using EVVEB. Once you have created you message, containing one or more ADRs, you can validate, send, and save this message (on XML or RTF format) using the buttons on the “Dynamic button set”. 2 – Create & Send Acknowledgements
This section used to create and send “Acknowledgement” messages to the messages containing “ADR” that you have received from other users. Details on how to create and send acknowledgements are given on a separate step-by-step tutorial. 3 – Web Trader
The WEB Trader section allows web trader users to keep track of sent and received safety and acknowledgement messages. The messages are filed in two folders, an Inbox and an Outbox. These folders work in a similar way as any email system, such as Outlook. On the Inbox, you will be able to see ADRs and acknowledgement messages other users have sent to you. On the Outbox, you will find the ADR and acknowledgement messages that you have sent to other organisations. To access a message, select it by clicking on it in the active area. Then click on the “Remote Import” button. The selected safety message will be loaded in the tree-view area. Please note that the set of dynamic buttons will change according to which section of the tree-view you are currently in. 5
LOCAL IMPORT:
The “Local import” button lets webtrader users to import XML files previously saved on their PC into EudraVigilance. This function can be used, for example, to create a “follow-up” to a previously sent message, or to import into the EudraVigilance system an “Electronic Simple Form” file sent to the user by a MAH.
A browse facility will allow you to select, from your PC, the files that you wish to send to the EudraVigilance DBMS.
Press “Upload file”, and you will get the following message. Press “OK”.
The message will be uploaded on the system. You will then get a message informing you that some of the fields on the file might not have been decoded during the import (when a message is sent through the EudraVigilance system, fields using VedDRA terms, pharmaceutical forms, etc are transmitted in a coded form):
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Press “OK”. You will then see the following screen:
Click “OK” if you want to review and double-check the contents of the file, otherwise press “Cancel”. When you click on “Cancel”, you will get to the next screen (below). Click on the “+” sign next to “Safety report”:
The report(s) contained in the message will be displayed. Click on the report ID as shown below:
The “Dynamic button set” toolbar changes; it now contains an “Edit” button. Click on “Edit”, and you will be taken to the “Create and Send ADRs” section, where you will be able to edit, complete, or enter further information on the case, and then send it to the EudraVigilance Database and any other relevant registered user.
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4 – ADRs
The “ADRs” section of EVWEB allows the user to perform simple and more advance administrative and scientific queries. Details on how to perform queries are given on a separate step-by-step tutorial.
5 – Create and Send Product Reports
This button gives access to the part of the application dedicated to the creation and modification (variations, etc) of Product Reports, which are sent as “Messages” to the database. There is a tutorial explaining how to create and send Product Report messages using EVVEB. Once you have created you message, containing one or more Product Reports, you can validate, send, and save this message (on XML or RTF format) using the buttons on the “Dynamic button set”.
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6 – Medicinal Products
The “Medicinal products” section of EVWEB allows the user to perform product queries. Details on how to perform queries are given on a separate step-by-step tutorial. 7 – VedDRA
The “VedDRA” section of EVWEB allows the user to perform queries related to the use of the VedDRA terminology. Details on how to perform queries are given on a separate step-by-step tutorial. 8 – Human VedDRA
The “Human VedDRA” section of EVWEB allows the user to perform queries related to the use of the Human VedDRA terminology. Details on how to perform queries are given on a separate step-bystep tutorial.
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