Name of define xml file

h Heidi

on March 28, 2017

Hi,

Using Pinnacle 21 Community to create a define XML the resulting define file is named "<study description>-<date/time>.XML".

Is it allowed to submit the define file named like this to FDA? Or is any specific file name required for the "define.XML" file?

Thanks and regards

Heidi

s Sergiy

on March 28, 2017

Hi Heidi,

Name of file submitted to FDA must be "define.xml".

This is a new eCTD Rejection rule.

Regards,

Sergiy.

h Heidi

on March 28, 2017

Thank you for the prompt reply, Sergiy

We're eager to share and ready to listen.

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