Clinical Data Management (CDM) – The Ultimate Overview

Clinical Data Management (CDM) – The Ultimate Overview, available at $44.99, with 49 lectures, 4 quizzes, and has 1 subscribers.

You will learn about Fundamentals of clinical data management, including data collection, storage, and analysis Regulatory Frameworks of Clinical Data Management What are Clinical Data Management Plan What are CRFs and how are they related to Clinical Data Management What are Informed Consent Forms Query Management in Clinical Data Management Database Locking Procedures How to develop a Statistical Analysis Plan What is a Clinical Study Report The trends and future of Clinical Data Management This course is ideal for individuals who are Clinical research associates and coordinators or Data managers and data entry personnel or Biostatisticians and data analysts or Pharmaceutical and biotechnology industry professionals or Graduate students and researchers in the field of clinical research or Anyone interested in learning more about Clinical Research, Clinical Trials and Clinical Data Management It is particularly useful for Clinical research associates and coordinators or Data managers and data entry personnel or Biostatisticians and data analysts or Pharmaceutical and biotechnology industry professionals or Graduate students and researchers in the field of clinical research or Anyone interested in learning more about Clinical Research, Clinical Trials and Clinical Data Management.

Enroll now: Clinical Data Management (CDM) – The Ultimate Overview

Summary

Title: Clinical Data Management (CDM) – The Ultimate Overview

Price: $44.99

Number of Lectures: 49

Number of Quizzes: 4

Number of Published Lectures: 49

Number of Published Quizzes: 4

Number of Curriculum Items: 53

Number of Published Curriculum Objects: 53

Number of Practice Tests: 2

Number of Published Practice Tests: 2

Original Price: $39.99

Quality Status: approved

Status: Live

What You Will Learn

Fundamentals of clinical data management, including data collection, storage, and analysis
Regulatory Frameworks of Clinical Data Management
What are Clinical Data Management Plan
What are CRFs and how are they related to Clinical Data Management
What are Informed Consent Forms
Query Management in Clinical Data Management
Database Locking Procedures
How to develop a Statistical Analysis Plan
What is a Clinical Study Report
The trends and future of Clinical Data Management

Who Should Attend

Clinical research associates and coordinators
Data managers and data entry personnel
Biostatisticians and data analysts
Pharmaceutical and biotechnology industry professionals
Graduate students and researchers in the field of clinical research
Anyone interested in learning more about Clinical Research, Clinical Trials and Clinical Data Management

Target Audiences

Clinical research associates and coordinators
Data managers and data entry personnel
Biostatisticians and data analysts
Pharmaceutical and biotechnology industry professionals
Graduate students and researchers in the field of clinical research
Anyone interested in learning more about Clinical Research, Clinical Trials and Clinical Data Management

Welcome to “Clinical Data Management (CDM) – The Ultimate Overview,” a comprehensive course designed for professionals and students eager to master the essential principles and practices of clinical data management. In the fast-paced world of clinical research, effective data management is crucial for the success of trials and the integrity of research findings.

What You Will Learn:

Fundamentals of Clinical Data Management: Understand the key concepts, terminology, and processes involved in CDM, including data collection, validation, and analysis.
Regulatory Compliance: Gain insights into the regulatory landscape governing clinical trials, including Good Clinical Practice (GCP) and the role of regulatory authorities such as the FDA and EMA.
Data Management Lifecycle: Explore the entire data management lifecycle, from study design and data collection to database lock and reporting, ensuring you grasp each critical step.
Data Quality Assurance: Learn techniques for ensuring data accuracy and reliability, including data cleaning, validation checks, and audit trails.
Technology in CDM: Discover the latest tools and technologies used in clinical data management, including Electronic Data Capture (EDC) systems and data analytics software.
Practice: Practice your new skills with quizzes and practice tests.

This course is ideal for clinical research associates, data managers, biostatisticians, and anyone involved in clinical trials or interested in pursuing a career in clinical data management. Whether you are a beginner or looking to enhance your existing knowledge, this course provides valuable insights and practical skills.

Enroll today and take the first step towards mastering Clinical Data Management!

Course Curriculum

Chapter 1: Introduction

Lecture 1: Introduction

Lecture 2: Download the course materials

Chapter 2: The Basics of Clinical Data Management

Lecture 1: What is Clinical Data Management (CDM)

Lecture 2: What is a Clinical Trial

Lecture 3: What is Clinical Research

Lecture 4: Importance of data integrity, quality, and compliance in clinical trials

Lecture 5: Objectives of Clinical Data Management (CDM)

Lecture 6: Roles in Clinical Data Management

Lecture 7: Glossary of related terms (Part 1) – 40 important terms to know

Lecture 8: Glossary of related terms (Part 2) – 40 important terms to know

Lecture 9: Glossary of related terms (Part 3) – 40 important terms to know

Chapter 3: Regulatory Framework and Ethical Considerations

Lecture 1: Overview of Clinical Trial regulations

Lecture 2: Ethical data considerations in clinical trials

Lecture 3: Understanding the role of Institutional Review Boards (IRBs)

Chapter 4: Clinical Data Management – Planning Phase

Lecture 1: Clinical Trial Protocol

Lecture 2: Developing a Clinical Data Management Plan (CDMP)

Lecture 3: Designing case report forms (CRFs)

Chapter 5: Clinical Data Management – Data Collection & Entry Phase

Lecture 1: Informed Consent Forms – template reviewed included in lesson

Lecture 2: Data collection methods

Lecture 3: Electronic Data Capture (EDC) Systems

Chapter 6: Clinical Data Management -Data Cleaning and Validation Phase

Lecture 1: Key Steps in Data Cleaning and Validation for Clinical Data Management

Lecture 2: Pre-Entry data validation

Lecture 3: On-Entry data validation

Lecture 4: Post-Entry data validation

Lecture 5: Documentation of Data Cleaning Activities

Lecture 6: Regular Data Reviews

Lecture 7: Query Management in CDM – OpenClinica example

Chapter 7: Clinical Data Management – Data Integration and Analysis Phase

Lecture 1: Database Locking Procedures

Lecture 2: Statistical Analysis Plan (SAP)

Chapter 8: Clinical Data Management – Reporting Phase

Lecture 1: Clinical Study Report (CSR)

Chapter 9: Clinical Data Management – Post-Submission Phase

Lecture 1: Post-Market Surveillance

Chapter 10: Current Trends and Technologies in CDM

Lecture 1: Innovations in Clinical Data Management

Lecture 2: Future directions in clinical data management practices

Chapter 11: Optional Section – Data Quality

Lecture 1: Why learn more about Data Quality to improve your CDM

Lecture 2: Intro to Data Quality

Lecture 3: The Data Quality Dimensions

Lecture 4: Data Accuracy

Lecture 5: Data Validity

Lecture 6: Data Timeliness

Lecture 7: Data Completeness

Lecture 8: Data Uniqueness

Lecture 9: Data Consistency

Lecture 10: What are Data Quality rules

Lecture 11: Steps to Implement Data Quality rules

Lecture 12: Implementing data quality rules

Lecture 13: Implementing data quality rules – part 2

Chapter 12: Practice Test on Clinical Data Management

Chapter 13: Course Closure

Lecture 1: Next Steps

Lecture 2: Thank You

Lecture 3: Bonus Lecture

Instructors

George Smarts
Use software to become a productivity superstar

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Frequently Asked Questions

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You can view and review the lecture materials indefinitely, like an on-demand channel.

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