Clinical Data Management: An overview

Get introduced to the basic principles of clinical data management & learn how to manage clinical data
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17 students enrolled
Instructed by Sri C IT & Software / Other
$60
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  • Lectures 24
  • Length 2 hours
  • Skill Level Beginner Level
  • Languages English
  • Includes Lifetime access
    30 day money back guarantee!
    Available on iOS and Android
    Certificate of Completion
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About This Course

Published 6/2016 English

Course 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




What are the requirements?

  • Prior knowledge of clinical terminology is an added advantage but not a requirement

What am I going to get from this course?

  • 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

What is the target audience?

  • The target audience for this course is healthcare professionals

What you get with this course?

Not for you? No problem.
30 day money back guarantee.

Forever yours.
Lifetime access.

Learn on the go.
Desktop, iOS and Android.

Get rewarded.
Certificate of completion.

Curriculum

03:20

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

02:56

Get familiar with learning objectives and  curriculum of the course

Section 1: Clinical data managment(CDM) Overview
00:52

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

03:41

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

04:47

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

3 questions

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

Section 2: Clinical Data Management process & activities
Introduction
Preview
01:09
05:12

Understand the process of Clinical Data Management

04:05

Understand Data Management Plan and it's scope

03:04

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

06:13

Understand CRF and it's design considerations

08:07

Understand Clinical Database structure & design

06:07

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

05:00

Understand the considerations in clinical database setup & testing

02:40

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

06:21

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

06:20

Get  an overview of discrepancy management & types of discrepancies 

05:00

Understand medical coding and it's methods 

09:30

Understand  the process of SAE reconciliation and steps involved in CDM

02:21

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

05:20

Get an overview of QC activities in CDM

03:32

Get familiar with database lock & it's activities

04:08

Understand what components are archived and purpose of electronic archival

3 questions

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

Section 3: Tools & responsibilities in CDM
02:41

Get familiar with various free & commonly used tools in CDM

03:46

Understand the roles & responsibilities  of key members in CDM team

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Instructor Biography

Sri C, 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

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