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MedDRA Credentials
1. How to generate MedDRA API Key to use in Onevigilance You can register for an API key via the following page: https://mid.meddra.org/account/register Provide your MedDRA subscription ID in the username field Provide your MedDRA subscription ...
Login / Logout
In this section you will learn to: Log in Onevigilance Log out Onevigilance 1. (First) Login To log in to the IWRS system: A random password and access instructions will be sent to your email The login page will be available in the following link: ...
Access and exit a client
Access "Pharmacovilgilance Clients" from the main menu: Now simply choose your client from that new list by clicking on the eye-like symbol: And you are inside your client. To exit just hit the "Exit Client" button on the top right of the same ...
Create a new ICSR
To create a new ICSR access your Client section. On the action buttons of table "All adverse events/adverse reactions", you'll see the button to create new ICSRs: A form will pop-up: After adding the Case Report Code of your choice, click "Add" and ...
Import an E2B XML file into an ICSR
When inside an ICSR, you will see in the "Case Report information" section the button to "Import E2b XML File": Clicking that button will display the following pop-up: Click on "Choose File", select a valid E2B XML file of your choice and then click ...