Data Management In Clinical Trials
Published 10/2024
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz
Language: English | Size: 434.22 MB | Duration: 2h 9m

Mastering Data Management: Explore EDC Systems, Regulatory Compliance, Data Quality, and Emerging Technologies in Clinic

What you'll learn

Understand the fundamental principles and best practices of clinical data management in clinical trials.

Use key tools and technologies such as electronic data capture (EDC) systems, while adhering to regulatory standards.

Design clinical trial databases, ensure data quality, and apply security measures to protect patient privacy and confidentiality.

Implement data standards such as CDISC (SDTM and ADaM) in clinical trials, facilitating data integration and analysis.

Apply techniques for data validation, cleaning, and analysis, and generate statistical reports in compliance with regulations.

Prepare and submit data to regulatory authorities, ensuring adherence to international requirements

Explore emerging technologies like artificial intelligence, machine learning, and blockchain to enhance efficiency and security in clinical data management.

Requirements

Not required

Description

This 10-module course provides a thorough and comprehensive exploration of data management in clinical trials, covering both foundational principles and cutting-edge developments in the field. Participants will gain in-depth knowledge about how data is organized, structured, and managed across all phases of a clinical trial, ensuring that the data maintains its quality, integrity, and security throughout the entire process. The course delves into essential topics such as data collection methodologies, the utilization of electronic data capture (EDC) systems, and the adherence to global standards like CDISC (Clinical Data Interchange Standards Consortium). It also addresses critical privacy regulations, including GDPR and HIPAA, ensuring that participants understand the legal and ethical aspects of handling clinical data.Further, the course highlights the processes involved in preparing clinical trial data for submission to regulatory bodies, such as the FDA and EMA, focusing on the importance of meeting specific technical and formatting requirements. In addition to these core components, the course examines recent innovations in the field, such as the integration of artificial intelligence, blockchain technologies, and real-world data (RWD) in clinical trials. These modules provide participants with a forward-thinking perspective, equipping them with the tools and knowledge to navigate the evolving landscape of clinical data management.

Overview

Section 1: Introduction to Data Management in Clinical Trials

Lecture 1 Introduction to Data Management in Clinical Trials

Section 2: Data Collection Methods and Tools

Lecture 2 Data Collection Methods and Tools

Section 3: Data Standards in Clinical Trials

Lecture 3 Data Standards in Clinical Trials

Section 4: Data Quality Management

Lecture 4 Data Quality Management

Section 5: Data Privacy and Security in Clinical Trials

Lecture 5 Data Privacy and Security in Clinical Trials

Section 6: Database Design and Build

Lecture 6 Database Design and Build

Section 7: Data Integration and Interoperability

Lecture 7 Data Integration and Interoperability

Section 8: Statistical Analysis and Reporting

Lecture 8 Statistical Analysis and Reporting

Section 9: Data Submission to Regulatory Authorities

Lecture 9 Data Submission to Regulatory Authorities

Section 10: Future Trends in Data Management for Clinical Trials

Lecture 10 Future Trends in Data Management for Clinical Trials

Section 11: Exam

Professionals in the pharmaceutical and biotechnology industries looking to enhance their knowledge of data management in clinical trials.,Clinical research coordinators, monitors, biostatisticians, and data managers involved in clinical trials.,Personnel from contract research organizations (CROs) and clinical trial sponsors.,Students and recent graduates in fields such as health sciences, biomedicine, statistics, and technology.,Anyone interested in understanding how data is managed within the context of clinical trials, including regulatory and technological aspects.