Integral Plugin

Integral is a database system for secure storage of study data and analyses. Integral provides a secure data management system with complete auditing capabilities. The combination of Integral and Phoenix provides an effective means to share source data, models, scripts, and results among the members of a drug development team. The combination also supports compliance with the U.S. Food and Drug Administration’s 21 CFR Part 11 regulation.

Phoenix can work in conjunction with Integral for secure storage and change tracking for data and analyses. This section covers the use of Phoenix as an Integral client: loading Integral data to Phoenix and saving data from Phoenix as Integral projects and savepoints. Integral can also be accessed by way of a Web interface, which provides additional operations. See “Integral Introduction”.

This section contains the following topics:

Accessing the Integral browser

Adding a savepoint project

Defining the settings for a savepoint project

Confirming changes

Saving updated projects to Integral

Saving Phoenix Project as a Savepoint

Adding items to Integral

Loading Integral items in Phoenix

Detaching an item in Phoenix from Integral

Setting up a connection

Configuring default save options

Using PKS scenarios and Integral