PK Submit

Create SDRG and Define Files

When PK Submit > Create SDRG and Define Files menu item is selected, PK Submit creates a define.xls file and a Study Data Reviewer’s Guide in the Phoenix project Documents folder that have all the required fields populated.

The Study Data Reviewer’s Guide is a Word document consisting of the following sections:

•Introduction: Purpose, Acronyms, Study Data Standards and Dictionary Inventory.

•Protocol Descriptions: Protocol Number and Title

•Subject Data Description: Overview, Annotated CRFs

•Data Conformance Summary: Conformance Inputs, Issues Summary, Additional Conformance Details

•Inclusion/Exclusion Criteria Appendix

•Conformance Issues Details Appendix

It is based on the template available on the PhUSE website.

Export SAS Transport Files

When the PK Submit > Export SAS Transport Files menu item is selected, use the Browse for Folder dialog to specify the location for the new files. When OK is clicked, PK Submit creates SAS transport files for all domains: pc.xpt, pp.xpt, co.xpt, relrec.xpt and pooldef.xpt (Sparse analysis only).