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Posted Thu, 04 Jul 2024 08:41:10 GMT by Anneke Luppes
I have entered all KBE for quality, nonclinical and clinical measures. I have generated the application form, but this does not include all KBE (design, objectives, outcome measures, etc). Is there a way to extract this information from IRIS to make it easier to have the information entered checked within my company?
Posted Tue, 09 Jul 2024 10:47:00 GMT by Paolo Tomasi EMA
At present, the "Application form" generated by IRIS when clicking on the button in the submission form, or when the application is actually submitted after completion, includes a table of proposed studies and measures that contains a selected subset of the key elements. A User story to change the application form so that all key elements are included has been added to the IRIS backlog (193557 - Improve the "Application form" document for Initial PIPs, Modification, PSW and Compliance check [all structured data to be included in the document]).
Possible workarounds are to paste the key elements into IRIS from an existing document, or to take screenshots of the webforms, or even to use a web scraping algorithm or software. 

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