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

1. Introduction .............................................................................................................. 41.1 Objective........................................................................................................... 52. Overview of the Registration Process ...................................................................... 52.1 Apply for a Test Account................................................................................... 62.2 Test Account Setup and Approval..................................................................... 72.3 Send a Test Submission ................................................................................... 72.4 Apply for a Production System Account............................................................ 72.5 Production System Account Setup and Approval.............................................. 72.6 Send Submissions to the Production System ................................................... 83. Preparatory Activities ............................................................................................... 83.1 Submit Letter of Non-Repudiation Agreement .................................................. 83.2 Obtain Digital Certificate ................................................................................... 83.3 Understand Submission Guidelines .................................................................. 83.4 Naming Conventions....................................................................................... 103.5 Determine Submission Method....................................................................... 113.6 Connection Requirements .............................................................................. 133.7 Help and Information....................................................................................... 144. FDA ESG Web Interface Electronic Submissions .................................................. 144.1 Apply for a Test Account................................................................................. 144.2 Test Account Setup and Approval................................................................... 224.3 Send a Test Submission ................................................................................. 224.4 Apply for a Production System Account.......................................................... 314.5 Production System Account Setup and Approval............................................ 314.6 Send Submissions to the Production System ................................................. 314.7 Sending Large (> 7.5 GB) Submissions.......................................................... 324.8 Tracking Submissions..................................................................................... 334.8.1 The Submission Process ......................................................................... 334.8.2 Message Delivery Notifications (MDNs) and Acknowledgements............ 334.8.3 Message IDs and Core IDs...................................................................... 344.8.4 Accessing MDNs and Acknowledgements............................................... 365. AS2 Gateway-to-Gateway Electronic Submissions................................................ 365.1 Apply for a Test Account................................................................................. 365.2 Test Account Setup and Approval................................................................... 375.3 Send a Test Submission ................................................................................. 385.4 Apply for a Production System Account.......................................................... 385.5 Production System Account Setup and Approval............................................ 395.6 Send Submissions to the Production System ................................................. 395.7 Sending Large (> 7.5 GB) Submissions.......................................................... 395.8 Common AS2 Errors....................................................................................... 406. References/Resources........................................................................................... 41Appendix A. Troubleshooting the FDA ESG Web Interface .......................................... 42Appendix B. Creating tar Files and Compressing Files for Submission......................... 44