Clinical Data Management: An overview
3.9 (5 ratings)
Instead of using a simple lifetime average, Udemy calculates a course's star rating by considering a number of different factors such as the number of ratings, the age of ratings, and the likelihood of fraudulent ratings.
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Clinical Data Management: An overview

Get introduced to the basic principles of clinical data management & learn how to manage clinical data
3.9 (5 ratings)
Instead of using a simple lifetime average, Udemy calculates a course's star rating by considering a number of different factors such as the number of ratings, the age of ratings, and the likelihood of fraudulent ratings.
32 students enrolled
Created by Sri C
Last updated 6/2016
English
English, ...
  • English
  • English
Current price: $17 Original price: $70 Discount: 75% off
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Includes:
  • 2 hours on-demand video
  • Full lifetime access
  • Access on mobile and TV
  • Certificate of Completion
What Will I Learn?
  • The overall purpose of this course is to make you familiarize with CDM& provide an overview of the tools & standards adopted as well as the roles & responsibilities in CDM.Upon completion of this course you will be able to
  • Describe CDM process & its significance
  • Understand CDM activities
  • Get familiarize with variable roles in CDM
View Curriculum
Requirements
  • Prior knowledge of clinical terminology is an added advantage but not a requirement
Description

This course provides an easy understanding of clinical data management and processes involved for generation of high quality clinical trials data that helps in faster commercialization of product

Learn Basics Of Clinical Data Management With This Comprehensive Course

Get familiar with Clinical data Management 

Learn Phases & activities in CDM

Identify tools & roles in CDM

Master to manage clinical data by  CDM activities

Clinical Data management is essential to the overall research function,as its key deliverable is the data to support the submission.

CDM has evolved in response to the ever-increasing demand from pharmaceutical companies to fast-track the drug development process and from the regulatory authorities to put the quality systems in place to ensure generation of high-quality data for accurate drug evaluation. 

Contents and overview

This course is designed to introduce the concept of clinical data management and data management activities for beginners in healthcare industry covering 24 video lectures with 2 hours content & 2 end of module quizzes.

Section 1 starts with an overview of clinical data management,discussing what is clinical data management and regulations,standards implemented in CDM.

Section 2 outlines CDM process,data management plan  and describe activities involved in different phases of data management.

Section 3 gives an overview of variable tools used in CDM and key members involved in CDM team with their responsibilities

At the end of the course,you will able to 

  • Understand clinical data management and it's role in clinical  research
  • Describe activities involved in CDM process
  • Demonstrate functions of key members in CDM and variable tools available for CDM




Who is the target audience?
  • The target audience for this course is healthcare professionals
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Curriculum For This Course
24 Lectures
01:46:12
+
Introductory lecture
2 Lectures 06:16

Get introduced to what's the course about,target audience and stuff covered

Preview 03:20

Get familiar with learning objectives and  curriculum of the course

Preview 02:56
+
Clinical data managment(CDM) Overview
3 Lectures 09:20

You will get an overview of module 'Clinical Data Management(CDM) '.

Preview 00:52

Understand what is clinical data management & it's role in clinical research

Introduction to CDM
03:41

Get an overview and understand the regulations,guidelines & standards implemented in CDM 

Preview 04:47

This assessment tests your knowledge on topics covered in Clinical Data Management Overview module

Module 1 assessment
3 questions
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Clinical Data Management process & activities
17 Lectures 01:24:09

Understand the process of Clinical Data Management

CDM Process Overview
05:12

Understand Data Management Plan and it's scope

DMP development
04:05

You will get an overview of study start up phase & it's activities

Study Startup Process
03:04

Understand CRF and it's design considerations

CRF Design
06:13

Understand Clinical Database structure & design

Database design
08:07

Get familiar with types of  validation checks  & their role in CDM

Validation checks
06:07

Understand the considerations in clinical database setup & testing

Database setup & testing
05:00

You will get an overview of study conduct phase & it's activities

Study conduct process
02:40

Get to know data entry & methods in CDM,explaining it's role

Data Entry
06:21

Get  an overview of discrepancy management & types of discrepancies 

Discrepancy management
06:20

Understand medical coding and it's methods 

Medical coding
05:00

Understand  the process of SAE reconciliation and steps involved in CDM

SAE reconciliation
09:30

You will get an overview of study close out phase & it's activities

Study Closeout Process
02:21

Get an overview of QC activities in CDM

Quality Control
05:20

Get familiar with database lock & it's activities

Database lock
03:32

Understand what components are archived and purpose of electronic archival

Electronic Archival
04:08

This assessment tests your knowledge on topics covered in Clinical Data Management Process & Activities module

Module 2 assessment
3 questions
+
Tools & responsibilities in CDM
2 Lectures 06:27

Get familiar with various free & commonly used tools in CDM

Tools in CDM
02:41

Understand the roles & responsibilities  of key members in CDM team

Roles & responsibilities in CDM
03:46
About the Instructor
Sri C
3.9 Average rating
5 Reviews
32 Students
1 Course
M.S Life Sciences

With over 2+yrs of cross-functional experience across various industry verticals,got expertise with 

1. Writing SAS programs to generate tables, listings, and figures and analysis datasets.

2.Macro development

3. Knowledge of clinical and pharmaceutical drug    development and associated ICH/GCP guidelines

4. Converting the legacy data into CDISC-SDTM data standards

5.Experience of  extracting,manipulating,summarizing,analyzing and presenting data using SAS procedures

* Please note discounts may be slightly higher than advertised amount due to rounding and currency conversion.