Clinical Data Management (Cdm) - The Ultimate Overview

Mastering Clinical Data Management: Learn and build a successful career in Clinical Trials and Research

What you'll 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

Requirements

Basic understanding of data terms will be helpful but not necessary.

Description

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!

Overview

Section 1: Introduction

Lecture 1 Introduction

Lecture 2 Download the course materials

Section 2: The Basics of Clinical Data Management

Lecture 3 What is Clinical Data Management (CDM)

Lecture 4 What is a Clinical Trial

Lecture 5 What is Clinical Research

Lecture 6 Importance of data integrity, quality, and compliance in clinical trials

Lecture 7 Objectives of Clinical Data Management (CDM)

Lecture 8 Roles in Clinical Data Management

Lecture 9 Glossary of related terms (Part 1) - 40 important terms to know

Lecture 10 Glossary of related terms (Part 2) - 40 important terms to know

Lecture 11 Glossary of related terms (Part 3) - 40 important terms to know

Section 3: Regulatory Framework and Ethical Considerations

Lecture 12 Overview of Clinical Trial regulations

Lecture 13 Ethical data considerations in clinical trials

Lecture 14 Understanding the role of Institutional Review Boards (IRBs)

Section 4: Clinical Data Management - Planning Phase

Lecture 15 Clinical Trial Protocol

Lecture 16 Developing a Clinical Data Management Plan (CDMP)

Lecture 17 Designing case report forms (CRFs)

Section 5: Clinical Data Management - Data Collection & Entry Phase

Lecture 18 Informed Consent Forms - template reviewed included in lesson

Lecture 19 Data collection methods

Lecture 20 Electronic Data Capture (EDC) Systems

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

Lecture 21 Key Steps in Data Cleaning and Validation for Clinical Data Management

Lecture 22 Pre-Entry data validation

Lecture 23 On-Entry data validation

Lecture 24 Post-Entry data validation

Lecture 25 Documentation of Data Cleaning Activities

Lecture 26 Regular Data Reviews

Lecture 27 Query Management in CDM - OpenClinica example

Section 7: Clinical Data Management - Data Integration and Analysis Phase

Lecture 28 Database Locking Procedures

Lecture 29 Statistical Analysis Plan (SAP)

Section 8: Clinical Data Management - Reporting Phase

Lecture 30 Clinical Study Report (CSR)

Section 9: Clinical Data Management - Post-Submission Phase

Lecture 31 Post-Market Surveillance

Section 10: Current Trends and Technologies in CDM

Lecture 32 Innovations in Clinical Data Management

Lecture 33 Future directions in clinical data management practices

Section 11: Optional Section - Data Quality

Lecture 34 Why learn more about Data Quality to improve your CDM

Lecture 35 Intro to Data Quality

Lecture 36 The Data Quality Dimensions

Lecture 37 Data Accuracy

Lecture 38 Data Validity

Lecture 39 Data Timeliness

Lecture 40 Data Completeness

Lecture 41 Data Uniqueness

Lecture 42 Data Consistency

Lecture 43 What are Data Quality rules

Lecture 44 Steps to Implement Data Quality rules

Lecture 45 Implementing data quality rules

Lecture 46 Implementing data quality rules - part 2

Section 12: Practice Test on Clinical Data Management

Section 13: Course Closure

Lecture 47 Next Steps

Lecture 48 Thank You

Lecture 49 Bonus Lecture

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