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
Description

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
Requirements
  • 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
    00:22:38
  • Recording of Event
    00:11:15
  • Medical Management of Adverse Events
    00:09:43
  • Handling Death
    00:04:22
  • Unblinding of Drug
    00:02:47
  • Clinical Safety and Pharmacovigilance
    00:24:38
  • E2A- Clinical Safety and Data Management
    .
  • Media 436
    .
  • Naranjo Assessment
    .
  • Order and Formulate to Determine the Quantum
    .
  • SAE Reporting
    .
  • Safety Reporting- Quiz
    00:00:00
Pharmacovigilance
7 Lessons 01:50:46 Hours
  • Overview of PV
    00:14:23
  • History of PV
    00:10:44
  • ADR Classifications
    00:16:54
  • AE_SAE Reporting Process
    00:15:34
  • Introduction to Aggregate Reporting
    00:07:27
  • Medical Assessment -1
    00:15:29
  • Medical Assessment -2
    00:30:15
Clinical Data Management
12 Lessons 03:20:21 Hours
  • CDM- 21 CFR Part 11
    00:15:10
  • CRF Design_2
    00:26:16
  • Introduction to CDM
    00:10:44
  • Data Entry Methods
    00:15:19
  • Query Management
    00:20:14
  • Source data validation
    00:26:29
  • Future of Data Management
    00:07:08
  • Clinical Trial Start Up
    00:28:43
  • Clinical Trial Conduct
    00:28:59
  • Clinical Trial Close Out
    00:21:19
  • Clinical Data Management- Notes
    .
  • Clinical Data Management- Quiz
    00:00:00
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About instructor

Vaishali Deshpande

92 Reviews | 792 Students | 15 Courses
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