Oracle Clinical Fundamentals
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Oracle Clinical Fundamentals

The comprehensive program that covers the process of Clinical Data Management using the Oracle Clinical application.
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0.0 (0 ratings)
Instead of using a simple lifetime average, Udemy calculates a course's star rating by considering a number of different factors such as the number of ratings, the age of ratings, and the likelihood of fraudulent ratings.
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Created by Project 24
Last updated 9/2017
English
English [Auto-generated]
Price: $200
30-Day Money-Back Guarantee
Includes:
  • 2 hours on-demand video
  • Full lifetime access
  • Access on mobile and TV
  • Certificate of Completion
What Will I Learn?
  • Understand the User Interface of the Oracle Clinical application
  • Login to Oracle Clinical and understand the terminology and processes
  • Plan and Design a Clinical Study within Oracle Clinical
  • Design Data Entry Screens from CRFs within Oracle Clinical
  • Generate and Test Data Entry screens
  • Program Validation Procedures in Oracle Clinical
  • Perform Data Entry from completed CRFs into Oracle Clinical
  • Manage Discrepancies within Oracle Clinical
  • Issue, Print and Resolve Data Clarification Forms (DCFs) within Oracle Clinical
View Curriculum
Requirements
  • Basic knowledge of Clinical Research and Clinical Data Management Processes
Description

Clinical Data Management is an allied science that deals with the collection, cleaning, management and extraction of raw clinical data generated during clinical trials. Oracle Clinical is the de-facto standard for managing this clinical data. It is used by most Fortune 500 Pharma companies and CROs as the preferred software for managing clinical data during clinical research.

Oracle Clinical Fundamentals is a e-Learning program 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. 

At the end of this Program you will be eligible for the following job roles:

  • Clinical Data Entry Associate/Lead Data Entry Associate
  • Clinical Database Designer
  • Clinical Database Programmer
  • Clinical Data Coordinator
  • Clinical Data Manager
Who is the target audience?
  • Clinical Research Professionals who wish to upgrade their skills
  • Clinical Data Managers who want to have functional knowledge of Oracle Clinical
  • Pharma students wanting to foray into Clinical Data Management
  • Clinical Research associates, Clinical Data Coordinators, Clinical Monitors
  • Clinical Data Entry Associates, Clinical Data Coordinators
  • Students pursuing Clinical Research courses elsewhere
  • Medical and Healthcare Students
Compare to Other Oracle Clinical Courses
Curriculum For This Course
14 Lectures
02:04:09
+
Oracle Clinical - Navigation and Overview
3 Lectures 27:20

In this session we will learn the process of Installing and setting up the Jinitiator Plugin which is required for Logging into the Oracle Clinical application.

Preview 02:24

This session will introduce you to the Oracle Clinical application and the process of Navigating through it. At the end of the session you will be able to:

  • Install the J-Initiator Plugin required to load the Login applet
  • Login to the Oracle Clinical application
  • Understand the various User Interface Elements of the Oracle Clinical Application.
Preview 07:39

This session will provide you an Overview of the Oracle Clinical application and its User Interface. At the end of the session you will be able to:

  • Understand the Oracle Clinical User Interface
  • Enumerate the Subsystems of Oracle Clinical
  • Understand the Functionality of each Subsystem as applies to Clinical Data Management
Oracle Clinical Overview
17:17

This Assessment tests your understanding of the concepts covered in Section 1 titled 'Oracle Clinical - Navigation and Overview'

Assessment (C1-OCNO)
10 questions
+
Oracle Clinical - Planning a Study
1 Lecture 07:33

This session will discuss the process of Planning a Clinical Study within the Oracle Clinical application. At the end of the session you will be able to:

  • Setup Programs
  • Create Projects
  • Create and Assign Compounds to the Program
  • Create Organisational Units
  • Create Regions
  • Setup a Planned Study
Planning a Clinical Study
07:33

This Assessment tests your understanding of the concepts covered in Section 2 titled 'Oracle Clinical - Planning a Study'

Assessment (C2-OCSP)
10 questions
+
Oracle Clinical - Designing a Clinical Study
1 Lecture 16:47

This session will discuss the process of Designing a Clinical Study within the Oracle Clinical application. At the end of the session you will be able to:

  • Create a Study using Easy Study Design
  • Define Study Intervals
  • Setup Clinical Planned Events (CPEs)
  • Assign Treatment Patterns
  • Create Patient Positions
  • Create Investigators and Sites
  • Setup Study Site
Designing a Clinical Study
16:47

This Assessment tests your understanding of the concepts covered in Section 2 titled 'Oracle Clinical - Designing a Clinical Study'

Assessment (C3-CSD)
10 questions
+
Oracle Clinical - Global Library (GLIB)
3 Lectures 20:54

This session will discuss the process of Creating Discrete Value Groups (DVGs) within the Oracle Clinical application. At the end of the session you will be able to:

  • Understand Discrete Value Groups and its attributes in Oracle Clinical
  • Create Discrete Value Groups in the Global Library
  • Activate Discrete Value Group
Creating Discrete Value Groups (DVGs)
06:43

This session will discuss the process of Creating Questions within the Oracle Clinical application. At the end of the session you will be able to:

  • Understand Questions and and their attributes in Oracle Clinical
  • Create Questions in the Global Library
  • Associate DVGs to Questions
  • Activate Questions
Creating Questions
07:46

This session will discuss the process of Creating Question Groups within the Oracle Clinical application. At the end of the session you will be able to:

  • Understand Question Groups and and their attributes in Oracle Clinical
  • Create Question Groups in the Global Library
  • Associate Questions to the Question Groups
  • Activate Question Groups
Creating Question Groups
06:25

This Assessment tests your understanding of the concepts covered in Section 3 titled 'Oracle Clinical - Global Library (GLIB)'

Assessment (C4-GLIB)
15 questions
+
Oracle Clinical - Definition subsystem
3 Lectures 16:01

This session will discuss the process of creating Data Collection Modules (DCMs) within the Oracle Clinical application. At the end of the session you will be able to:

  • Understand Data Collection Modules (DCMs) and and their important attributes
  • Create DCMs in the Definition subsystem
  • Associate Question Groups to DCMs
  • Activate DCMs
Creating Data Collection Modules (DCMs)
06:02

This session will discuss the process of creating Data Collection Instruments (DCIs) within the Oracle Clinical application. At the end of the session you will be able to:

  • Understand Data Collection Instruments (DCIs) and and their important attributes
  • Create DCIs in the Definition subsystem
  • Associate DCMs to DCIs
  • Activate Data Collection Instruments (DCIs)
Creating Data Collection Instruments (DCIs)
05:23

This session will discuss the process of Generating and Testing the Layout of the Data Entry screens within the Oracle Clinical application. At the end of the session you will be able to:

  • Understand what is a Character Layout
  • Generate Character Layout from a DCM
  • Edit a Character Layout to make it look like the CRF
  • Validate the Character Layout
  • Test the Final Data Entry Screen
Generating and Editing Form Layouts
04:36

This Assessment tests your understanding of the concepts covered in Section 4 titled 'Oracle Clinical - Definition subsystem'

Assessment (C5-OCSD)
15 questions
+
Oracle Clinical - Validation Procedures
1 Lecture 09:50

This session will discuss the process of Programming Validation Procedures within the Oracle Clinical application. At the end of the session you will be able to:

  • Define a Validation Procedure and its Importance in Data Management
  • Design a Validation Procedure 
  • Program the Boolean logic for the Procedure
  • Generate a Validation Procedure
  • Execute Validation Procedure against Test Data to check its Logic
Programming Validation Procedures
09:50

This Assessment tests your understanding of the concepts covered in Section 5 titled 'Oracle Clinical - Validation Procedures'

Assessment (C6-OCVP)
10 questions
+
Oracle Clinical - Data Entry
1 Lecture 10:06

This session will discuss the process of performing Production Data Entry from completed CRFs received from the Investigator into the Oracle Clinical application. At the end of the session you will be able to:

  • Understand the workflow of Data entry in Oracle Clinical
  • Perform Initial Login
  • Conduct First Pass Data Entry
  • Conduct Second Pass Data Entry
  • Make changes to the DCM data using the 'Update' module
  • Make changes to the Header data using the 'Key changes' module
Performing Production Data Entry
10:06

This Assessment tests your understanding of the concepts covered in Section 6 titled 'Oracle Clinical - Data Entry'

Assessment (C7-OCDE)
10 questions
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Oracle Clinical - Discrepancy Management
1 Lecture 15:38

This session will discuss the process of managing Discrepancies and Data Clarification Forms (DCFs) within the Oracle Clinical application. At the end of the session you will be able to:

  • Understand the Types of Discrepancies
  • Functionality of The Discrepancy Database
  • Process of Generating, Printing and Issuing DCFs
  • Process of Resolving received and completed Data Clarification Forms.
  • Understand the DCF Management Workflow
Discrepancy and DCF Management
15:38

This Assessment tests your understanding of the concepts covered in Section 7 titled 'Oracle Clinical - Discrepancy Management'

Assessment (C8-OCDM)
10 questions
About the Instructor
Project 24
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Digital Learning Academy for Clinical Research

Project 24 is a Digital Learning Academy for Clinical Research.

We offer eLearning Program in Clinical research, Clinical Data management and Pharmacovigilance.Our courses are self-paced and delivered through recorded lectures, Quizzes, Assignments and Discussion Forums.

Our courses include hands-on practical training on Oracle Life science applications used in the industry such as Oracle Clinical, Argus Safety etc.