Create Submission Files

Select PK Submit > Create Submission Files.

In the dialog, optionally enter a study name, a description of the study and a protocol name to use in the files.

Click OK.

The following files for submission are generated, with all of the required fields populated, and stored in the Documents folder of the Phoenix project in subfolders, depending on their extension:

Define.xml file

Define.xslx file

Data Reviewer’s Guide

Domain files in xpt format.

The Data Reviewer’s Guide is a Word document that is based on the template available on the PhUSE website. It will vary depending on the standard selected. For SEND, the Non-Clinical Study Data Reviewer’s Guide (nsdrg) is generated. For SDTM, the Study Data Reviewer’s Guide (sdrg) is generated.

When STDM is the standard and AdaM data is imported, the output will also include a Define Adam.xlsx, Define ADaM.xml, and Analysis Data Study Guide (adrg) file