Oracle Clinical

Oracle Clinical – Live Online

$999.00

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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.

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