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Clinical Data Management - Industry Perspectives

This course is designed to provide students with an overview of the clinical data management process, including the elements involved in CRF designing, Programming, data collection and management, data quality assurance and assurance processes.

Beginner 0(0 Ratings) 21 Students enrolled English
Created by Mrs Supraja Raghunathan
Last updated Sat, 06-May-2023
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Course overview

This course is designed to provide students with an overview of the clinical data management process, including the elements involved in CRF designing, Programming, data collection and management, data quality assurance and assurance processes. Students will gain an appreciation for how clinical data are collected and managed throughout the healthcare system. They will learn about how to identify sources of error in clinical data records, perform analysis on their own health information, understand best practices for data analysis and interpretation

The field of clinical data management (CDM) has come about due to the requirement from both relating to medicinal drugs/device industry and the regulatory authorities for the development of medicinal products continues to accelerate, regulatory entities by requiring quality-assurance standards to be met in collecting the data used in the drug/device evaluation process. 

The content and methodology of our courses are structured to complement self-directed learning. As such, participants will be able to review course material at their own pace, however, should complete the course within the allocated time provided for the course.

What will i learn?

  • Introduction to Data management
  • Clinical data management Lifecycle
  • CRF Designing and Programming Edit checks
  • Planning, implementation and data validation
  • Data capture and presentation
  • Query Management
  • Clinical Data Extraction and review
  • Clinical data quality assurance and quality control
  • Introduction to documents involved in all phases of Data management (Start Up Phase, Conduct Phase and Closeout Phase)
  • Career Opportunities
Requirements
  • This course is open to all individuals, especially the graduating individuals/Freshers in Pharmacy/Life science/Science domain, Engineering & Technology and Trainees seeking to obtain a general overview of the Clinical Data Management and to understand the scope & opportunities exist in the industry.
Curriculum for this course
14 Lessons 04:48:09 Hours
General Module - Pharmaceutical Industry – Opportunities
1 Lessons 00:36:53 Hours
  • General Module - Pharmaceutical Industry – Opportunities
    Preview 00:36:53
Module 1 - Data Management
1 Lessons 00:18:27 Hours
  • Module 1 - Data Management
    Preview 00:18:27
Module 2 - Clinical Data Management
1 Lessons 00:15:49 Hours
  • Module 2 - Clinical Data Management
    00:15:49
Module 3 - Start-up phase
1 Lessons 00:25:54 Hours
  • Module 3 - Start-up phase
    00:25:54
Module 4 - Conduct Phase
1 Lessons 00:26:03 Hours
  • Module 4 - Conduct Phase
    00:26:03
Module 5 - E-CRF Designing and Edit Check Programming
1 Lessons 00:38:08 Hours
  • Module 5 - E-CRF Designing and Edit Check Programming
    00:38:08
Module 6 - 21 CFR Part 11
1 Lessons 00:16:38 Hours
  • Module 6 - 21 CFR Part 11
    00:16:38
Module 7 - Data Management Plan
1 Lessons 00:27:21 Hours
  • Module 7 - Data Management Plan
    00:27:21
Module 8 - Data Validation Guideline
1 Lessons 00:24:00 Hours
  • Module 8 - Data Validation Guideline
    00:24:00
Module 9 - Quality Control Guideline
1 Lessons 00:16:56 Hours
  • Module 9 - Quality Control Guideline
    00:16:56
Module 10 - Edit Checks
1 Lessons 00:16:10 Hours
  • Module 10 - Edit Checks
    00:16:10
Module 11 - Closeout Phase
1 Lessons 00:10:50 Hours
  • Module 11 - Closeout Phase
    00:10:50
Live Interaction
1 Lessons 00:00:00 Hours
  • Live Interaction
    Preview .
Quiz
1 Lessons 00:15:00 Hours
  • Quiz - Multiple Choice Questions
    0:15:00
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About instructor

Mrs Supraja Raghunathan

0 Reviews | 20 Students | 1 Courses
Clinical Data Management Quality Assurance Quality Control Good Clinical Practice
Mrs Supraja Raghunathan holds a Master Degree in NeuroScience from University of Madras, Tamil Nadu. She started with her career in 2014 as a Data Analyst in THINQ Pharma CRO Ltd a...
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