Legacy data

a Anne

on July 25, 2022

Can Pinnacle21 Enterprise a provide a define.xml for legacy analysis datasets (non-compliant ADaM)?

We were asked to do new ISS and ISE analysis, for a label change, on several NDA original studies from as far back as 2007.

We created ADaM-like datasets from the original raw data for this analysis.

Since this data will be submitted for the label update, we assume that a define.xml should be included.

Forums: Define.xml

Sergiy

on July 25, 2022

P21

Hi Anne, All questions…

Hi Anne,

All questions related to Enterprise should be submitted through Enterprise Support. This forum is for Community users.

Formally, FDA doesn't require define file in XML format for legacy data. You may use PDF instead. However, these days almost all sponsors use XML format. Enterprise export can do either or both options.

In general, Define.xml tool including Community can handle legacy data. For example, I know that some uses utilize it to create BIMO deifne.xml file claiming ADaM standard.

What kind of problems do you have when using Define.xml generator? Please contact Enterprise Support.

Kind Regards,
Sergiy