1 System Overview

Oracle Clinical is a database application that streamlines clinical trial management. It provides tools to manage all of clinical trial activities from your organizational infrastructure to preparing your results for submission. The foundation of the application is a flexible data model with the following features:

• A Global Library of reusable objects

• A comprehensive set of tools for capturing the components of the clinical trial protocol

• A flexible method for structuring the questions that appear on Case Report Forms (CRFs)

• Automated procedures for generating and customizing data entry windows (forms) that correspond to the CRFs

• Tools to define complex data validations and derivations that require little or no programming

• A discrepancy database automatically synchronized with changes to both the clinical trial data and the validation definitions

• A flexible internal data structure for storing the clinical trial data that provides the ability to reorganize data for extract

• Tools to maintain lab reference ranges across multiple studies

Oracle Clinical's Main Parts

At the highest level, Oracle Clinical is organized around seven major clinical trial activities. There is a navigation aid for each of these activities in the application's navigation panel. These are the menu items:

• Design

• Definition

• Conduct

• Extract

• Administration

• Lab ranges

• Global Library

The following sections summarize the functions of each of the major subsystems that comprise the top level of Oracle Clinical's navigation panel.

About the Administration Subsystem

The Administration subsystem includes all functions that support other Oracle Clinical subsystems. Specific functions include the following items:

• Reference codelists

• Data Entry administration

• Global Library administration

• User account maintenance

• System security

• Replication

See the Oracle Clinical Administrator's Guide guide for more information.

About the Plan Subsystem

Use the Plan subsystem to model your organizational infrastructure and to create planned studies. You can define Programs, Organizational Units, Regions, and Planned Studies to model your organization's infrastructure.

See the Oracle Clinical Creating a Study guide for more information.

About the Design Subsystem

Design provides a facility to capture the detailed design of a clinical study as described in the study protocol. Use the Design system to define your studies, Investigator and Site records, Treatments, Strata, Randomization strategy, and Patient Position records.

See the Oracle Clinical Creating a Study guide for design information, and the Oracle Clinical Conducting a Study guide for runtime information.

About the Global Library

The Global Library is the central repository for the objects that compose data collection definitions for clinical studies. In addition, you can store standard versions of the study collection objects for reuse in other studies. You can define separate domains, or namespaces, within the Global Library for different purposes, and you can classify objects in the Library to provide guidance for their use.

These are the definitions you manage in the Global Library:

• Questions — The elementary units of data collection comprising data point.

• Question Groups — A group of questions that have a logical relationship to each other that you usually collect together.

• Discrete Value Groups — A list of the valid responses to a question.

• Data Collection Modules— Organize question groups into the sets that are collected together.

• Data Collection Instruments — Organize data collection modules to facilitate data entry from Case Report Forms.

• Extract macros, Where clauses, key templates, view templates, and view definitions — Allow user-defined data extract and data browse.

The Global Library provides the facility to create and copy certain objects, as well as storing them. You can also define their required and recommended usage of the library objects for particular types of clinical studies and the tools for monitoring compliance with these standards.

See the Oracle Clinical Creating a Study guide for more information.

About the Definition Subsystem

The Definition subsystem covers four basic activities:

• Creating data collection modules (DCMs), data collection instruments (DCIs), and, optionally, DCI Books, which describe the data to be collected for a study.

• Creating data entry windows corresponding to the data collection modules.

• Assigning the data collection modules to the clinical planned events at which they are to be collected.

• Creating Validation and Derivation Procedures for the data to be collected.

See the Oracle Clinical Creating a Study guide for more information.

About the Conduct Subsystem

Conduct deals with entering, tracking, and cleaning clinical trial data. This subsystem encompasses the following functions:

• Log-In — Enter key information that identifies CRFs and creates the CRF tracking database.

• Data Entry — Complete first-pass and second-pass (verification) data entry.

• Batch Data Load — Load data from electronic sources rather than by manual methods.

• Batch Validation —Execute Validation and Derivation Procedures on new and changed data.

• Discrepancy Management — Guide the data query and correction process by taking note of the discrepancies recorded in the discrepancy database.

• Data Update — Interactively correct data values through data entry windows.

• Data Freezing and Locking — Control access to data to prevent unauthorized modifications.

• Data Browse — Review data in the interactive data entry windows in a read-only mode.

• Study Conduct Reports — Run reports that help visualize the current state of data acquisition and monitor the overall progress of data collection.

See the Oracle Clinical Conducting a Study guide for more information.

About the Labs Subsystem

The Lab Reference ranges subsystem provides facilities for maintaining information about labs, and about the reference ranges for lab tests, performed at those labs. Oracle Clinical also provides functions to define the allowable units for specific lab tests and rules for converting between various units. Finally, you can define the criteria for associating a lab with particular studies, patients, visits, or forms, and you can override the default association for particular data.

Lab ranges are also available from within Oracle Clinical's validation and derivation procedures.

See the Oracle Clinical Creating a Study guide for design information, and the Oracle Clinical Conducting a Study for runtime information.

About Data Extract

Data Extract consists of activities to create and maintain Data Extract Views, as well to create SAS pass-through views and SAS datasets based on these views. You define your Data Extract Views in the Definition subsystem, and you extract data from the Conduct subsystem.

Data Extract Views are Oracle RDBMS view definitions that allow you to access the data stored in Oracle Clinical in the same way you would access any other data stored in an Oracle database. A view is a database object that you can query like a database table. You can query Oracle Clinical's views with any data query tool that can access Oracle tables— for instance, Oracle's Discoverer 3.1 or Oracle Reports.

See the Oracle Clinical Creating a Study guide for design information, and the Oracle Clinical Conducting a Study for runtime information.