Oracle Clinical Fundamentals

More than 250 pharmaceutical, biotechnology, medical device, and contract research organizations have relied on Oracle Clinical to conduct more than 10,000 clinical trials, making it the marketleading clinical research solution. Oracle Clinical’s scalability, ease of implementation, and built-in compliance increase your return on investment with each study you initiate.

Oracle Clinical, or OC, is a database management system designed by Oracle to provide data management, data entry and data validation functionalities to Clinical Trials process.

The Major Functions Supported by Oracle Clinical are:

• Clinical Study Protocol Definition and Management
• Definition of Metadata collected during a Clinical Study.
• Creation of Data Entry System
• Creation of Data Management System to clean and reconcile Data
• Validation Procedures
• Data Loading and Extracting
• Thesaurus Management System for Coding Medical Terms
• Laboratory Reference Range Management System

This course consists of presentations, demos, and exercises, inclusive of, but not limited to an overview of OC study planning and design, study set up, sites, investigators and patient positions, treatments and schedules, randomization, global library library activities, question groups, DCMs, DCIs, and DCI books, graphic layouts, annotating CRFs, copy groups, data extracts, lab ranges, validations, data entry, discrepancy management,DCFs, mass changes, loading data from electronic sources, graphic PDR and basic security.

Learn To:

• Work with basic feature/functions of Oracle Clincial
• Understand basic study design and set up
• Learn basics of data entry, data loading, and data extracts
• Understand a basic system overview of Oracle Clinical

Audience

• Application Developers
• Business Analysts
• Developer
• Functional Implementer
• End Users
• Data Warehouse Administrator
• Technical Consultant
• Database Administrators

Course Topics System Overview Planning and Designing a Study Easy Study Design Site Investigators and Patient Positions Treatments and Schedules Stratification and Randomization Global Library Activities Data Collection Modules Creating Graphic Layouts Annotating CRFs Data Extract Lab Ranges Validation and Derivation Procedures Test Mode Customizing Data Entry Screens Tracking DCMs Using the Discrepancy Database Using Data Clarification Forms (DCF) Making Mass Changes Loading Data from Electronic Sources Security Settings for Study Conduct Patient Data Reports
Course Objectives