Creating an eCTD Application and Assigning Users in SubMetro: A Step-by-Step Guide

In this guide, we will walk you through the process of creating an eCTD application within SubMetro and assigning roles to your team members.

Step 1: Create the Application

1. Initiate Application Creation: Click on the "Create Application" button.
2. Fill in Metadata: Enter the required metadata for the application, including:
   • Product name
   • Indication
   • Region
   • Application type
   • Application number

Step 2: Assign Roles to Team Members

1. Role Assignment: During the application creation process, you have the option to assign different roles to your team members. The available roles include:
   • Reviewers
   • Publishers
   • Program Managers
2. Assign Publisher: Select the name of the person you want to assign as the publisher.
3. Save and Add Sequence: Click on "Save and Add Sequence".

Step 3: E-Signature and Application Creation

1. Provide E-Signature: The system will prompt you to provide an e-signature. Enter your credentials and submit.
2. Complete Application Creation: Once the e-signature is provided, your eCTD application will be created.
3. Add Sequence: The system will then prompt you to add a sequence to the newly created application.

By following these steps, you can efficiently create an eCTD application in SubMetro and assign the necessary roles to your team members, ensuring a smooth and organized submission process.