Clinical Data Management (Cdm) - The Ultimate Overview

[mitsumi]

Clinical Data Management (Cdm) - The Ultimate Overview

Published 8/2024
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz
Language: English | Size: 1.69 GB | Duration: 3h 49m

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

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