Setting up a WebTrader Account Checklist

Checklist for Setting up a WebTrader Account for the FDA Electronic Submissions Gateway (ESG)

For assistance with ESG related items, please contact ESGHelpDesk@fda.hhs.gov.

Preparatory Activities
	1. Prepare an electronic Letter of Non-Repudiation Agreement. Then, upload your electronic Letter of Non-Repudiation Agreement during your WebTrader account registration process via the FDA ESG User Portal (https://esgportal.fda.gov/). Users are no longer required to submit a physical copy to the FDA. Submitting a physical copy is now optional. Click here for more information on Non-Repudiation Letters. Click here for additional steps pertaining to CROs, US Agents and Consultants.
	2. The ESG Account Management Portal provides the option to generate a free personal digital certificate during registration or to upload one you acquired from a CA. Click here for more information on certificates. Click here for more information on certificates.
	3. Optional: Prepare a guidance compliant test submission. Each FDA Center has published guidance on the preparation of electronic submissions. Refer to the specific center web site for information about guidance compliant submissions.
	4. Optional: Prepare a load test submission. Each FDA Center and protocol have different load test requirements. Refer to the load test web site for information about load test submissions.
	5. Read the following materials: ESG Account Management Portal User Guide ESG User Guide Tutorials WebTrader System Requirements
Register Your WebTrader Account
	6. Access the FDA ESG Account Management Portal website at https://esgportal.fda.gov/. Then, select the “New Account Registration” link below the Submit button on the Sign In screen. Follow the step-wise navigation to create a new ESG account. Please refer to the ESG Account Management Portal User Guide for instructions.
	7. Receive the account confirmation email.
Setup Your Machine
	8. Set up your ESG WebTrader Test (Pre-Production) environment: Download and review the WebTrader tutorial. Go to the WebTrader Test website: https://esgtest.fda.gov/. Enter your ESG WebTrader credentials (User ID and Password) from step 6 above. Download the required WebTrader Client Installer.
Send Test Submissions
	9. Send a test submission via WebTrader: Use your WebTrader Test User ID and Password to log into the ESG WebTrader Test application: https://esgtest.fda.gov/. If your company does NOT currently have any Production WebTrader accounts and you intend to send to FDA: Send a guidance compliant test submission via WebTrader Test to the appropriate FDA center with appropriate submission type. Each FDA Center has published guidance on the preparation of electronic submissions. Refer to the specific center web site for information about guidance compliant submissions. If your company has at least one Production WebTrader account and you intend to send submission to FDA: To ensure your WebTrader account works properly, send a test submission via WebTrader Test with the Center selected as "GWTEST" and the Submission Type selected as "ConnectTest". The FDA ESG team will review your test submission, migrate your account to production, and notify you within 24 hours. If you intend to send submissions via WebTrader to HC (Health Canada): All new accounts must send a TEXT file via WebTrader Test with the Center selected as "HC" and the Submission Type as "Transaction". Text file contents are not reviewed. The FDA ESG team will review your test submission, migrate your account to production, and notify you within 24 hours. Note, when sending ESG HC submissions via WebTrader, the guidance compliance test is NOT required for Health Canada.
	10. Optional: Send a Load Test submission with the Submission Type selected as "SizeTest" and to the center labeled "GWTEST". Refer to the load test website for information about load test submissions.
The FDA will review your guidance compliant test submission, which may take up to 1 week. Once it is approved, your account will be automatically migrated to the ESG Production environment.
Production Account Approval
	11. Once the center approves your guidance compliant submission, the FDA ESG team will migrate your account to production and notify you.
	12. Now, access the ESG WebTrader Production application: https://esg.fda.gov/. Provide your ESG WebTrader account credentials (User ID and Password) from step 6 above.
Log in to your ESG WebTrader production account with the same user ID and password you created when you registered for your test account (step 7 above).
You are now ready to send electronic submissions to FDA using the ESG WebTrader application.

For assistance with the registration or testing process, contact ESGHelpDesk@fda.hhs.gov. 

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