Online Course in CDM and PV : Part - 2

Get introduced to the basic principles of Clinical Data Management and Pharmacovigilance and be harnessed with knowledge and skills required to make a successful career

Advanced 0(0 Ratings) 4 Students enrolled English
Created by Vaishali Deshpande
Last updated Sat, 06-Apr-2024
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Course overview

You want to upgrade your skills and start a career in ever-growing clinical research industry in Clinical Data Management and Pharmacovigilance profiles, then this the course is perfect for you!

Start learning CDM and PV to start your career in the most growing field of Pharma & life-Science Industry!

Either you're completely brand new to Clinical Research, or you've played around it but want to get more comfortable with Clinical Research. Either way, this course will be great for you. Clinical Data Management (CDM) is an important phase in clinical research, which leads to the generation of high-quality, reliable, and statistically sound data from the clinical trials. Whereas Pharmacovigilance (PV) is also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products

What makes Did I qualify to teach you?

My name is Mrs. Deshpande and I've been in the Clinical Research domain for over Two decades. Plus I'm the creator of some of the most popular online courses - with over 2000+ students like these ones:

Awesome course, easy to follow! – Radha Jaiswal

Your course is amazing, so I can say that I am learning a lot. Your English is very easy to understand ( I'm from Brazil). Thanks for sharing your amazing knowledge. – Santosh Chame

My Promise to You

I'll be here for you every step of the way. If you have any questions about the course content or anything related to this topic, you can always post a question in the course or send me a direct message.

I want to make this the best course on CDM and PV. So if there is any way I can improve this course, just tell me and I'll make it happen.

What is this CDM and PV course all about?

In this complete guide, you'll not only learn all of the topics and segments of CDM and PV, but also how to implement in real Industry so that you can crack any interview and start your career with a bang.

What will i learn?

  • Become a Clinical Data Management and Pharmacovigilance Professional and work with world's leading Contract Research Organisations.
  • Understand more about adverse drug reactions
  • Get familiarize with various roles in CDM and PV
  • Ideally who has completed their graduation in science, pharmacy or ailed branch also who are interested in medicine field
Curriculum for this course
31 Lessons 06:26:30 Hours
Safety Reporting
12 Lessons 01:15:23 Hours
  • Adverse Event Reporting
  • Recording of Event
  • Medical Management of Adverse Events
  • Handling Death
  • Unblinding of Drug
  • Clinical Safety and Pharmacovigilance
  • E2A- Clinical Safety and Data Management
  • Media 436
  • Naranjo Assessment
  • Order and Formulate to Determine the Quantum
  • SAE Reporting
  • Safety Reporting- Quiz
7 Lessons 01:50:46 Hours
  • Overview of PV
  • History of PV
  • ADR Classifications
  • AE_SAE Reporting Process
  • Introduction to Aggregate Reporting
  • Medical Assessment -1
  • Medical Assessment -2
Clinical Data Management
12 Lessons 03:20:21 Hours
  • CDM- 21 CFR Part 11
  • CRF Design_2
  • Introduction to CDM
  • Data Entry Methods
  • Query Management
  • Source data validation
  • Future of Data Management
  • Clinical Trial Start Up
  • Clinical Trial Conduct
  • Clinical Trial Close Out
  • Clinical Data Management- Notes
  • Clinical Data Management- Quiz
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About instructor

Vaishali Deshpande

92 Reviews | 792 Students | 15 Courses
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