Description

Oracle Clinical Fundamentals is a Live Online course that covers the basic and advanced concepts of managing clinical trial data using the Oracle Clinical application. It is intended for students and clinical research professional who are willing to make a career in clinical data management using the Oracle Clinical platform.

The course includes hands-on practical training on the Oracle Clinical software which is the de-facto standard for management of clinical data used by most Fortune 500 companies today.

Oracle Clinical is used by pharmaceutical companies and Contract Research Organisations to collect, clean, manage, store and extract clinical data reported through CRFs. It ensures clean, accurate data is produced in time to be sent to the regulatory authorities. Most of these organisations require skilled manpower that have the theoretical knowledge of clinical data management processes and practical knowledge of performing data management tasks within Oracle Clinical so that they may be productive from the very start.

The Oracle Clinical Fundamentals program is made up of 1 module, 9 topics and 10 Quizzes. It covers all the clinical data management tasks performed in Oracle Clinical including Planning & Designing a study, Designing eCRFs, Generating and testing Data entry screens, Programming Validation Procedures, Performing Data Entry as well as Discrepancy and DCF management.

On completing your enrolment for the program you will instantly get access to our online learning portal and the Oracle Clinical software.

This course includes access to latest version of Oracle Clinical – version 5.4.0 for hands on practical experience.

The Oracle Clinical – Live Online sessions will be scheduled with the Faculty.

Find more information about the Oracle Clinical software – What is Oracle Clinical

Key Features

Live Online Sessions with the Faculty via Web-conferencing
24×7 access to the Oracle Clinical software
Training on actual CRFs used in the industry
Course Instructor support via Email
Full access to e-Learning Portal containing Video Tutorials.

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 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 Organisations 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

Certification

At the end of the course, students will be awarded a certificate of completion.

Duration

The duration of this program is 2 months.

Live Online Sessions shall be scheduled with the faculty once a week. You may select your preferred timings below:

Weekends at 10:00am EST OR
Weekdays at 10:00am EST

If you would like to request a specific schedule please discuss with our team and we will try our best to accommodate it.

Reviews

There are no reviews yet.

Be the first to review “Oracle Clinical – Live Online”

Oracle Clinical – Live Online