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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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Figure 6: Available Routing shows a sample directory and subdirectories that correspondto some of the available routing IDs. A complete list of routing IDs for the <strong>FDA</strong> <strong>ESG</strong> arein Figure 7: Submission Types Supported by the <strong>FDA</strong> <strong>ESG</strong>.8. Create subdirectories beneath the base integration pickup directory as shown, then dropthe documents that you wish to submit into the appropriate directory. For example, tosend an AERS report, place the document in the "<strong>FDA</strong>_AERS" directory.9. For multi-document submissions, the original directory structure must be converted to asingle file by using "tar" and then "gzip", and the resulting file must have an extension of.tar.gz for the <strong>FDA</strong> <strong>ESG</strong> to correctly recognize it as a multi-document submission. Youmust perform the tar and gzip procedure before dropping the file into the appropriatedirectory, since the Cyclone/Axway software does not know how to tar and gzip on itsown.Note: <strong>FDA</strong>_AERS and <strong>FDA</strong>_AERS_ATTACHMENTS submissions cannot be sentas multi-document submissions under any circumstances.

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