Steps for CROs, U.S. Agents and Consultants to obtain ESG accounts

If you are a CRO, U.S. Agent or Consultant, please use the following steps to create an ESG account:

1. Register for a single ESG account (WebTrader or AS2). Using a single account, you may submit for all of your clients.
2. Your company must obtain and submit a Letter of Authorization to FDA. Please make sure the Letter of Authorization lists your company name.
3. Your company must submit a Letter of Non-Repudiation to FDA.

 

FAQs for CROs or Consultants

1. How do I decide on which WebTrader account to use?
   1. Moving forward CROs, Consultants and US Agents will only be allowed to use 1 account for all of their clients. If you currently have multiple accounts, please pick one to be your unique WebTrader account. Once you have decided on your unique WebTrader account please send an email to ESGHelpDesk@fda.hhs.gov. Please let ESGHelpDesk@fda.hhs.gov know the following:
      1. Current Account Name
      2. What you’d like the new name to be – please remove any reference to client names in the account
      3. ESG will update your account name and routing ID for future use
2. What will happen to our old WebTrader accounts?
   1. In the short term all WebTrader accounts will remain untouched. In the future all unused WebTrader accounts may be retired. The ESG Help Desk will not install new certificates on any Unused WebTrader accounts
3. Do I have to change my WebTrader account name?
   1. You should change your WebTrader account name if it references a client’s name