Posted Tue, 02 Jul 2024 14:48:35 GMT by Nicola More Ms
Once a submission has been made, is it possible to download a copy of the submission for our internal records? the generated application form does not include all of the information entered to the submission itself (only a copy of the submission notes section is included). should the submission manager leave the company, how would the MAH access the information completed on the other sections of the submission in the future?
Posted Wed, 03 Jul 2024 09:16:08 GMT by Paolo Tomasi EMA
The generated application form is indeed downloadable, but for Paediatric procedures not all structured fields are currently included in the document, as tables would become unreadable if too many columns are added to them. As the submission and its data in structured fields are always accessible in the portal, a possible alternative for Industry would be to use a web scraping (screen scraping) application to download the information.

Regarding the second issue reported, if a submission contact (portal contact) leaves an organization, for draft or ongoing submissions a user with the role of "IRIS Industry coordinator" can add new users to the submission with the role of IRIS Industry manager, so that they can visualize all data. 

To address your suggestions, two user stories have been added to the IRIS development backlog:
  • 193553 - Extend addition of submission managers also to closed (completed) submissions, in the Industry Portal
  • 193557 - Improve the "Application form" document for Initial PIPs, Modification, PSW and Compliance check (all structured data to be included in the document)

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