PK Submit

Note: This content is specific for PK Submit 1.0. For information specific to version 1.1, see the PK Submit 1.1 User's Guide and Release Notes for PK Submit 1.1 (June 2020) PDF files.

PK Submit is a Phoenix Plugin designed to automatically generate the CDISC domains and supporting documentation relevant to non-compartmental analysis (NCA) used in electronic submissions to regulatory agencies as part of an Investigational New Drug (IND) or New Drug Application (NDA).

PK Submit supports the generation of CDISC domains in either the SDTM (Study Data Tabulation Model) or the SEND (Standard for Exchange of Nonclinical Data) format.

•CDISC SDTM is a unified way of transmitting information in drug studies with precise column names and a common file format. The CDISC STDM implementation in PK Submit is compliant with the standards in the SDTM Implementation Guide: Human Clinical Trials version 3.2.

•CDISC SEND is an implementation of SDTM for nonclinical studies and specifies a consistent format for presenting and exchanging nonclinical data. The CDISC SEND implementation in PK Submit is compliant with the standards in the SEND Implementation Guide: Nonclinical Studies Version 3.0/3.1.

For further information, please visit the Clinical Data Interchange Standards Consortium Web site at www.cdisc.org.

Using typical study data files as a starting point (.xls, .xlsx, .csv, pc.xpt, ex.xpt), PK Submit will do the following:

Produce Phoenix worksheets
Create Phoenix workflow NCA objects
Produce the following domain and file output:

•SEND Output: PC, PP, RELREC, POOLDEF, CO, Data Definition File, Non-clinical Study Data Reviewer’s Guide

•SDTM Output: PC, PP, RELREC, CO, Data Definition File, Study Data Reviewer’s Guide

Validation (Data Checking)
Validate PC, PP, POOLDEF, RELREC, CO according to CDISC Standards and FDA validation rules to generate a validation report.

By allowing the PC and PP domains to be generated contemporaneously by a Pharmacokinetic Scientist at the time of performing an NCA from a single source solves many of the challenges associated with documenting record exclusions and comments in these domains, as well as generating the RELREC and POOLDEF domains that explain how they were generated.

This section contains the following topics:

•Create PC Domain

•Add Exclusion and Comment

•Create PP Domain

•Create RELREC and POOLDEF Domains

•Create SDRG and Define Files

•Export SAS Transport Files

•Preferences

•CDISC time formats

•Constructed variables