PK Submit

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.

The CDISC ADaM implementation in PK Submit is compliant with the standards in the Analysis Data Model Implementation Guide Version 1.1.

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, PK Submit will do the following:

Produce Phoenix worksheets
Create Phoenix workflow NCA objects
Produce the requested domain and file output.
Validate the data according to CDISC Standards and FDA validation rules and generate a validation report.

Note:When updating the PK Submit Phoenix Plugin, be sure to uninstall the previous version of the Plugin before installing the newer version.

This section contains the following topics:

Create PC Domain
Add Exclusion and Comment
Create PP Domain
Create RELREC and POOLDEF Domains
Create Submission Files
Export Submission Files
Preferences
CDISC time formats
Constructed variables