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

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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
Appendix C. Digital Certificates................................................................................... 46Appendix D. Java Runtime Edition Installation........................................................... 54Appendix E. Glossary of Terms..................................................................................... 63Appendix F. Acronyms .................................................................................................. 65Appendix G. AS2 Header Attributes........................................................................... 66Appendix H. Sample Letters of Non-Repudiation Agreement ..................................... 68Appendix I. EDIFACT Message Structure .................................................................. 70Appendix J. Digital Signatures .................................................................................... 72Frequently Asked Questions about Digital Signatures............................................... 73Appendix K. AS2 Routing IDs ....................................................................................... 73
Page 1: FDA Electronic Submissions Gateway
Page 6 and 7: Figure 1: Overview of the Registrat
Page 8 and 9: 2.6 Send Submissions to the Product
Page 10 and 11: eCTD - Electronic Common Technical
Page 12 and 13: FDAPreparation of multi-filesubmiss
Page 14 and 15: 3.7 Help and InformationThere are r
Page 16 and 17: 4. Click the Next button.The Pick a
Page 18: 8. Click the Next button.The Locate
Page 21 and 22: 14. Enter a new login User ID and P
Page 23 and 24: Confirm that the correct version of
Page 25 and 26: 7. Select the Send document menu it
Page 27 and 28: - Load tests ensure that you are ab
Page 29 and 30: 20. To access the receipt, click on
Page 31 and 32: 4.4 Apply for a Production System A
Page 33 and 34: submissions (> 7.5 GB), this can ta
Page 35 and 36: When a Center receives a submission
Page 37 and 38: The following information is requir
Page 39 and 40: Be sure to indicate on the applicat
Page 41 and 42: - Create a local environment that s
Page 43 and 44: ___________________________________
Page 45 and 46: Upon receiving the file, signature
Page 47 and 48: or by obtaining a certificate from
Page 49 and 50: 3. Click on the Export button to cr
Page 51 and 52: 9. Give a file name and select the
Page 53 and 54:
4. Create a password for your priva
Page 55 and 56:
2. Select "Windows" from the platfo
Page 57 and 58:
2. Click on the link under Required
Page 59 and 60:
4. With the box unchecked, a warnin
Page 61 and 62:
. From the Add or Remove Programs d
Page 63 and 64:
Appendix E. Glossary of TermsTable
Page 65 and 66:
Appendix F. AcronymsA list of acron
Page 67 and 68:
Table G-1: Allowable Center Attribu
Page 69 and 70:
SAMPLE LETTER #1[Company Letterhead
Page 71 and 72:
EDIFACT UNB Header InformationDescr
Page 73 and 74:
Consult with an FDA Center represen
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Figure 3: File System Settings, Dir
Page 77 and 78:
6. Click on the Save changes button
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Figure 7: Submission Types Supporte
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