Clinical Data Management Essentials

Clinical Data Management Essentials

What you'll learn

Learn about clinical data management associated with clinical trials

Learn about associated aspects of data management, what are the different stages

Documentation associated importance and how keep things documented will help

Some best practices for all different stages of clinical data management

Requirements

Graduation done in any life science field like Bpharma or Mpharma but not limited to the same

Description

This course provides an in-depth introduction to Clinical Data Management (CDM), focusing on the key principles and practices necessary for effective management of clinical trial data. Students will gain hands-on experience in study setup, data collection, data entry, discrepancy management, and study closeout processes. The curriculum is designed to cover all regulatory requirements, ensuring that participants understand the importance of compliance and data quality assurance. Emphasis is also placed on the use of electronic data capture (eDC) systems, which are critical for modern clinical trials.Participants will learn how to design and maintain databases, manage data flow, and implement strategies for data validation and cleaning. The course also addresses common challenges in CDM and provides best practices for overcoming them. By the end of the course, students will be equipped with the skills to ensure data accuracy, integrity, and sustainability in clinical research.Whether you are new to the field or looking to enhance your existing knowledge, this course offers valuable insights and practical skills that can be applied immediately in a professional setting. Through a combination of lectures, hands-on exercises, and real-world case studies, participants will leave with a comprehensive understanding of clinical data management. So Happy learning and enjoy the experience.

Overview

Section 1: Introduction

Lecture 1 Introduction

Section 2: Study Set-up

Lecture 2 Protocol Review

Lecture 3 Creation Of Blank CRF or CRF Design

Lecture 4 Creation Of Edit Check Specification

Lecture 5 Creation Of Protocol Deviation Specification and CRF completion Guidelines

Lecture 6 Creation Of UAT documents along with performing UAT

Section 3: Study Conduct phase

Lecture 7 Discrepancy Management and Data Cleaning

Lecture 8 Vendor Management

Lecture 9 SAE reconciliation

Lecture 10 Local Lab review

Lecture 11 Study Metrics

Lecture 12 Protocol Deviation review

Section 4: Study Close-out Phase

Lecture 13 Complete details on the study close out phase

Beginners who would like to explore and learn about the field,Also for experience professionals who know about the aspect but want to brush up or relate back to the basics.