11i Clinical - Oracle Clinical Rel 4.5

What you will learn:
In this course, students will learn the major functions of the Oracle Clinical application. After an introduction consisting of an overview of Oracle Clinical subsystems, students will learn how to set up a basic Study by assigning sites and investigators and defining programs and projects. Class exercises will guide students through the process of completing the setup of a partially built study. Students will learn how to define Discrete Value Groups (DVG) and Questions and to create a simple Data Collection module (DCM) from Global Library Objects. Class exercises will guide students in simple and complex data modeling and the creation of a demographics DCM and DCI. The class also introduced the graphic design feature in Release 4.5. Student will learn about test vs production data entry, the batch load process, discrepancy management and validation and derivation procedures and will practice creating, reviewing and closing discrepancies and running validation and derivation procedures. Students will learn to define and access lab tests, labs and their ranges, to use the data extract process and different view types, and to perform data Locking and data Freezing.

Course Objectives:
Use the Oracle Clinical application to facilitate the clinical data management processes within their organizations.

Course Topics:

Day 1

• System Overview, Basic Study Setup
• Global Library Management

Day 2

• Simple CRF modeling
• CRF modeling for PDF

Day 3

• Data Entry
• Discrepancies, Data Clarification Form

Day 4

• Validations and Derivations
• Batch Data Loading, Laboratory Overview

Day 5

• Data Extract and Access from SAS
• Data Locking and Security, Copy Groups