Oracle Clinical Remote Data Capture Fundamentals

Oracle Clinical, or OC, is a database management system designed by Oracle to provide data management, data entry and data validation functionality to Clinical Trials process. Oracle’s Remote Data Capture (RDC) Onsite is fully integrated with Oracle Clinical (OC) – the leading clinical data management system.

Together, these products enable sponsor companies to streamline setup and manage execution of their full portfolio of studies through a single technology investment.

The Major Functions Supported by Oracle Clinical and RDC are:

• Clinical Study Protocol Definition and Management
• Definition of Meta data 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 2-day Oracle Clinical Remote Data Capture course consists of presentations, demos, and exercises, inclusive of, but not limited to an overview of RDC, data entry and discrepancy management, CRF verification and approval, basic administration in RDC, and new feature and functionality of Oracle's new version of RDC Onsite.

Learn To:

• Use Oracle's Remote Data Capture online data entry and discrepancy management tools
• Work in Oracle's newest version of RDC Onsite
• Work with basic feature/functions of Oracle Clinical Remote Data Capture

Audience

• End Users
• Project Manager
• Web Administrator
• Business Analysts

Course Topics Overview of Remote Data Capture

• CRFs
• RDC Workspace
• RDC Spreadsheet

GUI Reference

• General RDC Window
• Search Window
• PDF Mode
• Classic Mode
• Reports

Data Entry Management in PDF and Classic Modes

• Initial Data Entry
• Data Review and Update
• Study Closeout

Discrepancy Management

• Classifications
• Management Tool
• Managing Discrepancies

Document Verification and Approval

• Group Verifications
• Verification History
• Verification Task Hubs
• Approval Task Hub

Administering in RDC in Oracle Clinical

• Enrolling RDC Users
• Configuring the RDC Discrepancy System

RDC Administration GUI Reference RDC Administration Tasks

• Setting Study/Site Security Privileges
• Study Security Tasks
• RDC Site Security Tasks
• Work with RDC Configurator

Managing the Activity List

• Discussion
• Activity List Structure
• Defining an Activity

RDC Onsite
Course Objectives