Name: Diploma in Clinical Data Management – eLearning
SKU: 225036
Price: 499.00 USD
Availability: InStock

Description

The Diploma in Clinical Data Management – eLearning is a comprehensive online program designed to build knowledge across the key principles, processes, standards and systems involved in managing clinical trial data.

Through structured, self-paced learning, multimedia tutorials, recorded sessions, quizzes and assessments, you will explore how clinical data is collected, reviewed, validated, managed and prepared throughout the clinical data management lifecycle.

The program covers key areas including Clinical Data Management principles and processes, Data Management Plans, Case Report Form (CRF) design, clinical data acquisition, database design, data validation, query management, medical coding, regulatory standards, database closure, audits, data migration and archival.

The program also includes training/tutorial content covering Oracle Clinical and its role in clinical data management. Hands-on login access to Oracle Clinical software is not included with this eLearning option.

Looking for hands-on software training?

Explore the Diploma in Clinical Data Management with Oracle Clinical, which combines the Clinical Data Management curriculum with 24×7 access to Oracle Clinical for practical learning.

Explore Program with Oracle Clinical

Program at a Glance

5 Modules | 47 Topics | 44 Quizzes

3 Months | Self-Paced Online Learning | Certificate on Completion

What You’ll Learn

Clinical Data Management principles and processes
Data Management Plans and CDM documentation
Case Report Form (CRF) design and clinical data acquisition
Clinical database definition and design
Data entry, review and quality control
Data validation and query management
Discrepancy and Data Clarification Form (DCF) management
Medical coding dictionaries and MedDRA
Clinical Data Management standards, SOPs and audits
Database closure, migration and archival
Oracle Clinical concepts and clinical data management workflows

Who Is This Program For?

Students and graduates interested in Clinical Data Management
Life sciences, pharmacy, medical and healthcare graduates
Clinical research professionals exploring data management
Professionals transitioning into Clinical Data Management
Clinical Data Management professionals looking to strengthen their knowledge across key functional areas
Learners seeking flexible, self-paced Clinical Data Management 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 the Diploma in Clinical Data Management with Oracle Clinical. This option combines the complete Clinical Data Management curriculum with 24×7 software access for hands-on practice.

Explore Program with Oracle Clinical

New to Clinical Data Management? Explore our free learning resource on What is Clinical Data Management.

Explore more Clinical Data Management courses and training programs.

Key Features

Comprehensive Clinical Data Management curriculum covering key processes, standards and systems
5 modules, 47 topics and 44 quizzes
Multimedia tutorials and recorded sessions
Oracle Clinical training/tutorial content
Flexible, self-paced online learning
Quizzes and assessments to reinforce learning
Instructor support through discussion forums
Certificate of Completion

Curriculum

Module 1 – Introduction to Clinical Research

Pharmaceutical & Clinical Research – Industry Overview
Introduction to Clinical Research
Stakeholders and Roles in Clinical Research
History and Milestones in Clinical Research
Principles of Good Clinical Practice
Technologies in Clinical Trial Management
Overview of Clinical Research Regulatory Bodies

Module 2 – Basics of Clinical Data Management

Introduction to Clinical Data Management
Application of Computers in Pharmaceutical Research & Development
Data Management Plan
Case Report Form Design
Patient Registration
Clinical Data Acquisition
Clinical Data Definition and Database Design
Training, Education, and Documentation Requirements
Safety Data Management
CDM Documentation Overview

Module 3 – Clinical Data Management Processes and Standards

Data Entry Methods and Processes
Database Validation and Standards
Database Closure
Clinical Data Management Audits
Measuring Performance in CDM
Data Validation and Query Management
Process of Drug Development
Clinical Data Management Process
Standard Operating Procedures

Module 4 – Clinical Data Management Systems

Clinical Data Management Systems
Database Migration and Archival
Medical Coding Dictionaries and MedDRA
Software Tools Used in Clinical Trial Management
Laboratory Data
Receipt and Review of Data
Data Presentation
Oracle Pharmaceutical Application Suite

Module 5 – Oracle Clinical Fundamentals

This module provides learning content about Oracle Clinical. Hands-on software access is not included with this program.

Oracle Clinical Navigation
Oracle Clinical Overview
Oracle Clinical – Planning a Study
Oracle Clinical – Designing a Study
Oracle Clinical – Global Library (DVGs, Questions, Question Groups)
Oracle Clinical – Definition Subsystem (DCMs, DCIs, Layouts)
Oracle Clinical – Validation and Derivation Procedures
Oracle Clinical – Data Entry
Oracle Clinical – Discrepancy and DCF Management

Course Completion

Final Assessment
Course Certification

Certification

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

Duration

The program duration is 3 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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