Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,
Our vendor sent over a large zip file of the nonclinical datasets required for the IND. it included the xpt files but also excel define and pdf (with duplicate word) docs. Will FDA accept excel or do we need to convert everything to pdf and xpt?

Thank you.
Norma

The FDA Study Data Technical Conformance Guide recommends submitting the define files as an .xml file format. I recommend requesting the vendor to provide the define file in that format. If that is not possible, a pdf of the define may be accepted.

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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 04-Jan-2021 17:53
From: Anonymous Member
Subject: SEND dataset format?

This message was posted by a user wishing to remain anonymous

Hi,
Our vendor sent over a large zip file of the nonclinical datasets required for the IND. it included the xpt files but also excel define and pdf (with duplicate word) docs. Will FDA accept excel or do we need to convert everything to pdf and xpt?

Thank you.
Norma

We submit the .xpt files, a pdf reviewers guide and an excel definition file.

------------------------------
Kristina Chadwick
United States
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Original Message:
Sent: 04-Jan-2021 17:53
From: Anonymous Member
Subject: SEND dataset format?

This message was posted by a user wishing to remain anonymous

Hi,
Our vendor sent over a large zip file of the nonclinical datasets required for the IND. it included the xpt files but also excel define and pdf (with duplicate word) docs. Will FDA accept excel or do we need to convert everything to pdf and xpt?

Thank you.
Norma