Review Section 5 of the ESG NextGen Unified Submission Portal Guide for Industry Users to determine test submission approach.
Prerequisites
Create an Organization record in Veeva RIM with:
- DUNS number
- An Organization Type of Registration Holder
- This can be done by going to an Application Record (Submission Mgmt Tab Collection > Submission Mgmt > Application)
- Setting the Publish in Vault? field to Yes
- Going to the Publishing Details Section
- Clicking in the field for Applicant, and selecting +Organization
Create the following two Contact and Submission Contact records (be sure to include Contact Type, email, phone number type, phone number).
- Regulatory Contact
- Technical Contact
- This can be done by going to a Submission Record (Submission Mgmt Tab Collection > Submission Mgmt > Submissions)
- Go to the Contacts section under Submission relationships
- Click the +Create button
- Under the field for Contact, click +Create Contact and populate the relevant fields
As this is for a test submission, these do not need to be real people – you can create Regina Regulatory and Tina Technical if you wish.
Procedure
Connect Test Submission
Create a New Test Application as follows:
- Application Type: Investigational
- Application Number: 123456
- Region: North America
- Lead Market: United States
- Application Type: Investigational New Drug (IND)
- XML Application Number: 123456
- Application Folder Name: ind123456
- Health Authority: Food and Drug Administration
- Health Authority Center: Food and Drug Administration > GWTEST
Create and publish a New Submission 0001 as follows:
- Submission Type: Product Correspondence
- Subtype: Correspondence
- Gateway Format: ConnectTest
- Regulatory Contact: From prerequisites above
- Technical Contact: From prerequisites above
- Real fillable 1571 with application number and sequence fields completed (matching the test data)
- Sample cover letter
Progress the submission to the Ready for Submission State.
From the Actions Menu, select Submit to Gateway.
Verify the Dossier Status shows Transmission In Progress or Transmission Successful and Pending Acknowledgements is 1 (This should happen quickly)
Expand the Attachments section of the Submission
Open the log file that Veeva produces that starts with gateway_transmission_log
Refresh and wait for the MDN File to be uploaded by the FDA.
Open the MDN file (the first part of the file will be readable and indicate the MDN was successfully processed).
Check the submission every few minutes until the expected Acknowledgements is 0 and there are a total of 3 attachments on the submission.
Open the fda_atch_ack file and compare the following in the Dossier Details object associated with the Submission in Veeva RIM:
- Gateway Correlation ID matches CoreID in ACK
- Gateway Transmission ID matches Message ID in ACK
Per the Instructions from the FDA (https://www.fda.gov/industry/create-esg-account/setting-as2-account-checklist)
After you receive an Acknowledgement, please send an email to ESGHelpDesk@fda.hhs.gov with the Acknowledgement’s Core ID.
Guidance Compliance Test Submission
Note that this requires a different Application and Submission than the Connect Test.
Create a New Test Application as follows:
- Application Type: Investigational
- Application Number: 654321
- Region: North America
- Lead Market: United States
- Application Type: Investigational New Drug (IND)
- XML Application Number: 654321
- Application Folder Name: ind654321
- Health Authority: Food and Drug Administration
- Health Authority Center: Food and Drug Administration > CDER (or CBER)
Create and publish a New Submission 0001 as follows:
- Submission Type: Product Correspondence
- Subtype: Correspondence
- Gateway Format: ECTD for CDER / EIND for CBER
- Regulatory Contact: From prerequisites above
- Technical Contact: From prerequisites above
- Real fillable 1571 with application number and sequence fields completed (matching the test data)
- Sample cover letter
Progress the submission to your Ready for Submission state
From the Actions Menu, select Submit to Gateway.
Verify the Dossier Status shows Transmission In Progress or Transmission Successful and Pending Acknowledgements is 2 (This should happen quickly)
Expand the Attachments section of the Submission
Open the log file that Veeva produces that starts with gateway_transmission_log
Refresh and wait for the MDN File to be uploaded by the FDA:
Open the MDN file (the first part of the file will be readable and indicate the MDN was successfully processed).
Check the submission every few minutes until the expected Acknowledgements is 1 (this applies for CDER and CBER) and there are a total of 3 attachments on the submission.
Open the fda_atch_ack file and compare the following in the Dossier Details object associated with the Submission in Veeva RIM:
- Gateway Correlation ID matches CoreID in ACK
- Gateway Transmission ID matches Message ID in ACK
Note: 3rd ACK is not sent in Pre-Production environments