10.07.2015 Views

FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

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8. Select an <strong>FDA</strong> Center from the Center drop-down box. The Centers that can be selected atpresent are CBER, CDER, CDRH, CFSAN, CVM, GWTEST, and OOPD. Upon choosing aCenter, the Submission type drop-down box will be populated with the correct submission typesfor that Center.9. Single File <strong>Submissions</strong>: Click the Browse button associated with the Path textbox to selectthe test submission.10. Multi-File <strong>Submissions</strong>: Click the Browse button associated with the Root Directorytextbox to select the directory that contains all the files in the test submission. Make sure that thename of any file or sub-directory does not start with "." (dot). Note:the Path field is still requiredfor multi-file submissions. Make sure you have entered a path as well as a root directory.11. Select a test submission type from the Submission type drop-down box. About submissiontypes:- Connectivity tests ensure that your connection to the <strong>ESG</strong> is up and running. Theyshould be sent to the "Testing" Center.

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