Description

Oracle Clinical Fundamentals – eLearning is an online training program designed to build knowledge of how Oracle Clinical is used to manage clinical trial data. The program provides structured, self-paced learning through video tutorials, guided software demonstrations, quizzes and assessments.

Covering 1 module, 9 topics and 10 quizzes, the program introduces Oracle Clinical navigation and its core subsystems before progressing to clinical study planning and design, Global Library configuration, CRF design, validation and derivation procedures, data entry, discrepancy management and Data Clarification Forms (DCFs).

Through guided tutorials and software demonstrations, you will learn how clinical studies are configured, data collection structures are created, validation procedures are developed, clinical data is entered and reviewed, and discrepancies are managed within Oracle Clinical.

The program includes Oracle Clinical training/tutorial content. Hands-on login access to Oracle Clinical software is not included with this eLearning option.

Program at a Glance

1 Module | 9 Topics | 10 Quizzes

2 Months | Self-Paced Online Learning | Certificate of Completion

What You’ll Learn

Oracle Clinical navigation and core subsystems
Clinical study planning and configuration
Study visits, treatment patterns, sites and investigators
Questions and question groups using the Global Library
Data Collection Modules (DCMs) and Data Collection Instruments (DCIs)
Data entry screen generation and testing
Validation and derivation procedures
Clinical data entry and review processes
Discrepancy identification and management
Data Clarification Form (DCF) workflows

Who Is This Program For?

Students and graduates interested in Clinical Data Management
Clinical Data Management professionals looking to understand Oracle Clinical workflows
Clinical research professionals interested in clinical data systems
Data management professionals looking to strengthen their knowledge of Oracle Clinical
Life sciences, pharmacy, medical and healthcare graduates
Learners seeking flexible, self-paced Oracle Clinical training

Looking for Hands-On Oracle Clinical Training?

This eLearning program includes Oracle Clinical training/tutorial content but does not include login access to the software.

If you would also like to practise clinical data management activities directly within Oracle Clinical, explore Oracle Clinical Fundamentals with software access. This option combines the complete training curriculum with 24×7 Oracle Clinical access for hands-on practice.

Explore Program with Software Access

New to Oracle Clinical? Learn more in our free resource: What is Oracle Clinical?

Key Features

Comprehensive Oracle Clinical training/tutorial content
Structured video tutorials and guided software demonstrations
Training examples based on clinical study and CRF workflows
1 module, 9 topics and 10 quizzes
Flexible, self-paced online learning
Quizzes and final assessment to reinforce learning
Instructor support during the program
Certificate of Completion

Curriculum

Chapter 1 – Oracle Clinical Navigation

Logging into the application
User Interface – In Form Menu, Toolbar, Navigation
Shortcut Keys
Introduction to Forms

Chapter 2 – Oracle Clinical Overview

Overview of Oracle Pharmaceutical Applications
Core Subsystems of Oracle Clinical
Functionality of Each Subsystem in the Clinical Data Management Process

Chapter 3 – Planning a study

Process of Planning a clinical study in Oracle Clinical
Creating Programs
Associating Projects
Creating and Assigning Investigational New Drugs to Programs
Creating Organisational Units
Assigning Regions
Designing a Planned Study

Chapter 4 – Designing a study

Creating a study using Easy Study Design
Defining Intervals
Defining Study Visits/Clinical Planned Events (CPEs)
Creating and Assigning Treatment Patterns
Creating Patient Positions
Creating Sites and Investigators
Assigning Sites, Investigators and Patients to a Study

Chapter 5 – Global Library

Designing Discrete Value Groups (DVGs)
Designing Questions
Designing Question Groups

Chapter 6 – Definition subsystem

Designing Data Collection Modules (DCMs)
Repeating and Non-repeating Question Groups
Designing Data Collection Instruments (DCIs)
Generating Character Layout
Editing Character Layout
Testing Data Entry Screens

Chapter 7 – Validation and Derivation Procedures

Programming Validation Procedures
Generating Validation Procedures
Executing Validation Procedures on Test Data
Testing Validation Procedures Logic

Chapter 8 – Data Entry

Performing Initial Login
Conducting First Pass Data Entry
Conducting Second Pass Data Entry
Browse
Update
Performing Key Changes

Chapter 9 – Discrepancy Management

Interaction to Discrepancies and Discrepancy Management
Discrepancy Database – Profiles window
Discrepancy Database – Management window
Resolving Discrepancy In-House
Issuing Discrepancies to Investigator on a DCF
Printing DCFs
Managing and Closing Resolved DCFs
Passive Review

Course Completion

Final Assessment
Course Certification

The curriculum includes Oracle Clinical training and software demonstrations. Hands-on Oracle Clinical login access is not included with this eLearning program.

Certification

Upon successful completion of the program and final assessment, learners receive a ClinSkill Certificate of Completion.

Duration

The program duration is 2 months, with flexible, self-paced access to the online learning portal.

Learners have access to the course, including Oracle Clinical training/tutorial content, for the duration of the program. Login access to Oracle Clinical software is not included with this eLearning option.

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